Trial Outcomes & Findings for Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure (NCT NCT02032004)
NCT ID: NCT02032004
Last Updated: 2026-03-23
Results Overview
Non-fatal decompensated heart failure (HF) event was adjudicated when the diagnosis of a nonfatal decompensated HF event demonstrated the presence of signs and symptoms consistent with clinical decompensation of the participant's HF state requiring an in-hospital stay or intravenous (IV) diuretic therapy or aquapheresis during an urgent care outpatient HF visit. TCEs were defined as a composite of cardiac death, left ventricular assist device (LVAD) placement, heart transplant, or artificial heart implantation. Adjudication of all potential non-fatal HF-MACE or TCEs was performed by an independent, blinded Clinical Endpoints Adjudication Committee (CEC) based on the cardiac adjudication manual. Negative number in the time to event range indicates that event occurred to the subject before treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
565 participants
Primary outcome timeframe
Up to 71 months
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
Sham Control
Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
Rexlemestrocel-L
Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
|---|---|---|
|
Overall Study
STARTED
|
282
|
283
|
|
Overall Study
Safety Population
|
276
|
261
|
|
Overall Study
COMPLETED
|
193
|
192
|
|
Overall Study
NOT COMPLETED
|
89
|
91
|
Reasons for withdrawal
| Measure |
Sham Control
Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
Rexlemestrocel-L
Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
11
|
15
|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
|
Overall Study
Death
|
68
|
65
|
|
Overall Study
Reason not Specified
|
3
|
4
|
Baseline Characteristics
Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure
Baseline characteristics by cohort
| Measure |
Sham Control
n=282 Participants
Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
Rexlemestrocel-L
n=283 Participants
Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
Total
n=565 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 10.37 • n=10 Participants
|
62.7 years
STANDARD_DEVIATION 10.89 • n=8 Participants
|
62.7 years
STANDARD_DEVIATION 10.62 • n=18 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=10 Participants
|
61 Participants
n=8 Participants
|
122 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
221 Participants
n=10 Participants
|
222 Participants
n=8 Participants
|
443 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=10 Participants
|
18 Participants
n=8 Participants
|
35 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
265 Participants
n=10 Participants
|
265 Participants
n=8 Participants
|
530 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=10 Participants
|
59 Participants
n=8 Participants
|
110 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
218 Participants
n=10 Participants
|
213 Participants
n=8 Participants
|
431 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
10 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Up to 71 monthsPopulation: ITT Population included all participants randomly assigned to treatment (active or sham).
Non-fatal decompensated heart failure (HF) event was adjudicated when the diagnosis of a nonfatal decompensated HF event demonstrated the presence of signs and symptoms consistent with clinical decompensation of the participant's HF state requiring an in-hospital stay or intravenous (IV) diuretic therapy or aquapheresis during an urgent care outpatient HF visit. TCEs were defined as a composite of cardiac death, left ventricular assist device (LVAD) placement, heart transplant, or artificial heart implantation. Adjudication of all potential non-fatal HF-MACE or TCEs was performed by an independent, blinded Clinical Endpoints Adjudication Committee (CEC) based on the cardiac adjudication manual. Negative number in the time to event range indicates that event occurred to the subject before treatment.
Outcome measures
| Measure |
Sham Control
n=282 Participants
Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
Rexlemestrocel-L
n=283 Participants
Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
|---|---|---|
|
Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE)
|
29.70 months
Interval 0.0 to 68.3
|
27.53 months
Interval -0.3 to 65.2
|
Adverse Events
Sham Control
Serious events: 191 serious events
Other events: 260 other events
Deaths: 74 deaths
Rexlemestrocel-L
Serious events: 170 serious events
Other events: 244 other events
Deaths: 79 deaths
Serious adverse events
| Measure |
Sham Control
n=276 participants at risk
Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
Rexlemestrocel-L
n=261 participants at risk
Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure chronic
|
10.1%
28/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
9.2%
24/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Ventricular tachycardia
|
6.2%
17/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
9.6%
25/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Angina pectoris
|
4.7%
13/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.4%
14/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
11/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.4%
14/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Cardiac failure congestive
|
4.7%
13/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
4.2%
11/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.6%
10/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.9%
5/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Myocardial infarction
|
4.0%
11/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Cardiogenic shock
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
2.3%
6/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
2.3%
6/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Angina unstable
|
2.2%
6/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Mitral valve incompetence
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Atrial flutter
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Coronary artery disease
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Pericardial effusion
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Arrhythmia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Bradycardia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Cardiac perforation
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Palpitations
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Bundle branch block right
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Chronotropic incompetence
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Tachycardia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Pneumonia
|
6.2%
17/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.0%
13/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Sepsis
|
4.0%
11/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
2.3%
6/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Cellulitis
|
2.5%
7/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.9%
5/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
8/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Septic shock
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.9%
5/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Bacteraemia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Bronchitis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.5%
4/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Diverticulitis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.5%
4/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Device related infection
|
1.1%
3/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Gastroenteritis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Appendicitis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Cystitis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Osteomyelitis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Pneumonia bacterial
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Wound infection
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Arthritis bacterial
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Corona virus infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Erysipelas
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Implant site infection
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Influenza
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Localised infection
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Muscle abscess
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Perineal abscess
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Postoperative wound infection
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Staphylococcal infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Bacterial diarrhoea
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Breast abscess
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Bronchitis bacterial
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Bronchitis viral
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Campylobacter infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Cardiac valve vegetation
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Clostridium difficile infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Emphysematous cholecystitis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Enteritis infectious
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Fungal sepsis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Incision site infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Infectious pleural effusion
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Lung infection
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Parotitis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Periorbital cellulitis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Pneumonia influenzal
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Pneumonia pseudomonas aeruginosa
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Post procedural cellulitis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Respiratory tract infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Subcutaneous abscess
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Urosepsis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
11/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.5%
4/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.9%
8/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.9%
5/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.2%
6/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
2.3%
6/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
3/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Syncope
|
2.5%
7/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.0%
13/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.2%
6/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Dizziness
|
2.2%
6/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.8%
5/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Encephalopathy
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Presyncope
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Embolic stroke
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Headache
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Hypersomnia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Migraine
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Radiculopathy
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Spinal claudication
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Non-cardiac chest pain
|
2.9%
8/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
3.1%
8/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Death
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
2.7%
7/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Chest pain
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Device dislocation
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Asthenia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Device lead damage
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Fatigue
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Oedema
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Pyrexia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Device failure
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Device malfunction
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Multi-organ failure
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
BRCA2 gene mutation
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Catheter site haemorrhage
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Device electrical finding
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Device leakage
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Device occlusion
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Facial pain
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Hernia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Hypothermia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Impaired healing
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Implant site haematoma
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Implant site inflammation
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Medical device complication
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Medical device pain
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Medical device site reaction
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Pelvic mass
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Vaccination site reaction
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal failure acute
|
8.7%
24/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
8.8%
23/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.9%
5/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal failure
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Urinary retention
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Atonic urinary bladder
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Pneumaturia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal infarct
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal ischaemia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
3.8%
10/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
3/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Ascites
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Constipation
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Enteritis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Nausea
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Food poisoning
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Large intestinal ulcer haemorrhage
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
2.7%
7/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
3/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.5%
4/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.5%
4/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Gout
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Hypotension
|
2.5%
7/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
3.1%
8/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Haematoma
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Peripheral ischaemia
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Deep vein thrombosis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Orthostatic hypotension
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Hypertensive crisis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Aortic aneurysm
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Hypertension
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Venous occlusion
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Arterial insufficiency
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Haemorrhage
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Lymphorrhoea
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Peripheral artery dissection
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Shock
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
5/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Wound
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.1%
3/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Troponin increased
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Blood alcohol increased
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Blood creatinine increased
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Blood glucose increased
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Blood magnesium decreased
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Blood potassium decreased
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Blood pressure increased
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Cardiac enzymes increased
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Cardioactive drug level increased
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Heart rate increased
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
4/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
1.9%
5/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Completed suicide
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Mental status changes
|
1.1%
3/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Anxiety
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Delirium
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Depression
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.72%
2/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Hepatobiliary disorders
Cardiac cirrhosis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.77%
2/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Immune system disorders
Heart transplant rejection
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.38%
1/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/221 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.45%
1/222 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/221 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.45%
1/222 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.36%
1/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
0.00%
0/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
Other adverse events
| Measure |
Sham Control
n=276 participants at risk
Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
Rexlemestrocel-L
n=261 participants at risk
Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
|
|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
20.7%
57/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
21.5%
56/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Cardiac failure chronic
|
15.2%
42/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
13.4%
35/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Cardiac failure congestive
|
14.5%
40/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
9.2%
24/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Atrial fibrillation
|
12.3%
34/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
10.3%
27/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Angina pectoris
|
10.1%
28/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
6.9%
18/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Cardiac disorders
Ventricular fibrillation
|
5.4%
15/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
4.2%
11/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
26/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
11.1%
29/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Urinary tract infection
|
7.6%
21/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
8.0%
21/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Bronchitis
|
8.3%
23/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.7%
15/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
21/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.4%
14/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Influenza
|
5.1%
14/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.7%
15/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Infections and infestations
Sinusitis
|
6.2%
17/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
3.4%
9/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Nausea
|
14.1%
39/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
11.9%
31/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
27/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
7.3%
19/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Constipation
|
7.2%
20/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
9.2%
24/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
17/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
7.7%
20/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
17/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
4.6%
12/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.7%
13/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.7%
15/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Gout
|
8.3%
23/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
10.0%
26/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.9%
30/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
6.9%
18/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
23/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
8.8%
23/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.9%
44/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
15.7%
41/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
23/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
8.8%
23/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Fatigue
|
15.2%
42/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
13.8%
36/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Oedema peripheral
|
9.1%
25/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
11.5%
30/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
General disorders
Non-cardiac chest pain
|
6.9%
19/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
3.8%
10/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
29/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
10.0%
26/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
23/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
11.9%
31/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.6%
21/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.7%
15/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
22/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.0%
13/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Investigations
C-reactive protein increased
|
5.1%
14/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
3.8%
10/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Dizziness
|
10.5%
29/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
12.6%
33/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Headache
|
5.8%
16/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
6.1%
16/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Nervous system disorders
Syncope
|
4.7%
13/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.4%
14/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Vascular disorders
Hypotension
|
14.1%
39/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
11.9%
31/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Injury, poisoning and procedural complications
Fall
|
8.7%
24/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.7%
15/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal failure acute
|
8.7%
24/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
8.0%
21/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Renal and urinary disorders
Renal impairment
|
6.9%
19/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
6.9%
18/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.5%
18/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
9.2%
24/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Anxiety
|
6.9%
19/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
5.7%
15/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Insomnia
|
5.8%
16/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
4.2%
11/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
|
Psychiatric disorders
Depression
|
5.1%
14/276 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
4.2%
11/261 • From Day 0 up to end of study (Up to 71 months)
All-cause mortality: ITT Population included all participants randomly assigned to treatment (active or sham). Serious adverse events (AEs) and other AEs: Safety Population included all participants in the ITT Population (all participants randomly assigned to treatment \[active or sham\]) who underwent Day 0 index cardiac catheterization and in whom the interventional cardiologist was able to advance the pigtail catheter across the aortic valve and into the LV chamber.
|
Additional Information
Susan Sukovich, Senior Director, Regulatory Affairs
Mesoblast
Phone: 212-993-7950
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Publications (abstracts, posters or presentations) must be presented to the Publication Steering Committee for review prior to submission or public display and are not allowed prior to the publication of the primary manuscript, or eighteen (18) months from the conclusion of the Study. PI shall provide Sponsor a copy of any proposed public disclosure at least 30 days prior to submission. Sponsor may ask PI to delay the disclosure for a maximum of 60 days to file proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER