Trial Outcomes & Findings for PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve (NCT NCT03225001)
NCT ID: NCT03225001
Last Updated: 2021-03-09
Results Overview
The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
197 participants
Primary outcome timeframe
30-day
Results posted on
2021-03-09
Participant Flow
Participant milestones
| Measure |
Edwards SAPIEN XT THV in Patients With Failing SAVR
Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
|
|---|---|
|
Overall Study
STARTED
|
197
|
|
Overall Study
Valve-Implanted
|
195
|
|
Overall Study
COMPLETED
|
188
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - Nested Registry 3/Valve-in-Valve
Baseline characteristics by cohort
| Measure |
Edwards SAPIEN XT THV in Patients With Failing SAVR
n=197 Participants
Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
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|---|---|
|
Age, Continuous
|
78.5 Years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=99 Participants
|
|
STS Score
|
9.7 units on a scale
STANDARD_DEVIATION 5.1 • n=99 Participants
|
|
NYHA III/IV
|
188 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30-dayPopulation: Twenty-nine patients had missing echocardiography data.
The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak
Outcome measures
| Measure |
Edwards SAPIEN XT THV in Patients With Failing SAVR
n=166 Participants
Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
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|---|---|
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Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)
|
28 Participants
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SECONDARY outcome
Timeframe: 30 DaysCardiovascular cause is also included
Outcome measures
| Measure |
Edwards SAPIEN XT THV in Patients With Failing SAVR
n=195 Participants
Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
|
|---|---|
|
Number of Participants With Mortality From Any Cause
|
8 Participants
|
Adverse Events
Edwards SAPIEN XT THV in Patients With Failing SAVR
Serious events: 109 serious events
Other events: 142 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Edwards SAPIEN XT THV in Patients With Failing SAVR
n=195 participants at risk
Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
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|---|---|
|
Investigations
Abnormal Lab Value
|
1.5%
3/195 • Number of events 3 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Anemia/Hemolytic Anemia
|
1.5%
3/195 • Number of events 4 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Cardiac disorders
Angina/Cardiac Chest Pain
|
2.1%
4/195 • Number of events 5 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Cardiac disorders
Arrhythmia/Conduction System Injury (Defect)
|
5.6%
11/195 • Number of events 12 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Infections and infestations
Bacteremia
|
3.1%
6/195 • Number of events 8 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.1%
4/195 • Number of events 4 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Cardiac disorders
Cardiac Arrest
|
2.6%
5/195 • Number of events 5 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Nervous system disorders
Change in level of consciousness
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Compartment syndrome
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Coronary Flow Obstruction/Transvalvular flow disturbance
|
1.0%
2/195 • Number of events 2 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
5/195 • Number of events 7 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Embolization including air/calcific valve material or Thrombus
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Nervous system disorders
Encephalopathy
|
1.0%
2/195 • Number of events 2 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Infections and infestations
Endocarditis
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Failure of percutaneous access site closure resulting in intervention
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Fracture
|
3.1%
6/195 • Number of events 6 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Gastrointestinal disorders
Gastro Intestinal Event
|
2.6%
5/195 • Number of events 6 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Gastrointestinal disorders
Gastro Intestinal Event Nonhemorrhagic
|
3.1%
6/195 • Number of events 7 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Renal and urinary disorders
Genito Urinary Event
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Renal and urinary disorders
Genito Urinary Event Nonhemorrhagic
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Cardiac disorders
Heart Failure / CHF / Low output Failure
|
13.3%
26/195 • Number of events 28 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Hemorrhage
|
11.3%
22/195 • Number of events 22 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Nervous system disorders
Hemorrhagic Stroke
|
1.0%
2/195 • Number of events 2 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Hypertension
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Hypotension
|
1.5%
3/195 • Number of events 3 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Ischemic Stroke
|
2.1%
4/195 • Number of events 5 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Mitral Valve Injury or Insufficiency
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Investigations
Multi Organ Failure
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
3/195 • Number of events 3 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Non Structural Dysfunction
|
1.5%
3/195 • Number of events 3 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Nervous system disorders
Pain
|
3.6%
7/195 • Number of events 7 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Perforation
|
1.0%
2/195 • Number of events 2 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Pseudoaneurysm
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
2.1%
4/195 • Number of events 4 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Effusion
|
4.6%
9/195 • Number of events 10 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Renal and urinary disorders
Renal Failure
|
4.6%
9/195 • Number of events 10 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
9.2%
18/195 • Number of events 19 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
3.1%
6/195 • Number of events 6 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Restenosis
|
1.5%
3/195 • Number of events 3 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Rupture
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Infections and infestations
Sepsis
|
4.1%
8/195 • Number of events 8 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Syncope
|
1.5%
3/195 • Number of events 3 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
2/195 • Number of events 2 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Investigations
Unknown cause of Death
|
2.1%
4/195 • Number of events 4 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Investigations
Other
|
7.7%
15/195 • Number of events 18 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Infections and infestations
Urinary Tract Infection
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Investigations
Undetermined Stroke
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
TIA
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Hematoma
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
3/195 • Number of events 4 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Psychiatric disorders
Confusion
|
1.0%
2/195 • Number of events 2 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Infections and infestations
Access site infection
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Infections and infestations
Cough
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Psychiatric disorders
Dementia
|
0.51%
1/195 • Number of events 2 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Device Migration/malposition requiring intervention
|
1.0%
2/195 • Number of events 2 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Investigations
Drug Reaction
|
0.51%
1/195 • Number of events 1 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
Other adverse events
| Measure |
Edwards SAPIEN XT THV in Patients With Failing SAVR
n=195 participants at risk
Patients with a failing surgical bioprosthetic valve (SAVR) in the aortic position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN XT transcatheter valve.
Edwards SAPIEN XT transcatheter valve, Model 9300TFX: Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
|
|---|---|
|
Investigations
Abnormal Lab Value
|
11.8%
23/195 • Number of events 39 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Anemia/Hemolytic Anemia
|
11.8%
23/195 • Number of events 24 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Cardiac disorders
Arrhythmia/Conduction System Injury (Defect)
|
19.5%
38/195 • Number of events 42 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
12/195 • Number of events 13 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Cardiac disorders
Heart Failure / CHF / Low output Failure
|
6.2%
12/195 • Number of events 12 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Hemorrhage
|
20.5%
40/195 • Number of events 45 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Vascular disorders
Hypotension
|
5.1%
10/195 • Number of events 10 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Nervous system disorders
Pain
|
6.2%
12/195 • Number of events 19 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Effusion
|
5.6%
11/195 • Number of events 12 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Renal and urinary disorders
Renal Insufficiency or Renal Failure
|
8.2%
16/195 • Number of events 20 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
8.2%
16/195 • Number of events 16 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.8%
23/195 • Number of events 23 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Infections and infestations
Urinary Tract Infection
|
9.2%
18/195 • Number of events 18 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
|
Investigations
Other
|
25.6%
50/195 • Number of events 63 • 30-day
Site reported events Only Valve-Implant patients are analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place