Trial Outcomes & Findings for Edwards PASCAL Transcatheter Valve Repair System Registry (NCT NCT04443218)
NCT ID: NCT04443218
Last Updated: 2024-07-26
Results Overview
Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair \[TEER\] or mitral valve surgery)
COMPLETED
220 participants
30 days
2024-07-26
Participant Flow
Participant milestones
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
Overall Study
STARTED
|
220
|
|
Overall Study
COMPLETED
|
187
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
Overall Study
Exited study for other reasons
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Death
|
19
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
n=220 Participants
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
Age, Continuous
|
77.2 years
STANDARD_DEVIATION 9.61 • n=220 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=220 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=220 Participants
|
|
Body Mass Index
|
26.2 kg/m^2
STANDARD_DEVIATION 5.15 • n=218 Participants • Data unavailable for 2 patients
|
|
STS Score for Mitral Valve Repair
|
4.1 %
STANDARD_DEVIATION 3.11 • n=158 Participants • Data unavailable for 62 patients
|
|
EuroScore II
|
7.6 %
STANDARD_DEVIATION 8.20 • n=203 Participants • Data unavailable for 17 patients
|
|
New York Heart Association (NYHA) Functional Class
Class I
|
3 Participants
n=216 Participants • Data unavailable for 4 patients
|
|
New York Heart Association (NYHA) Functional Class
Class II
|
33 Participants
n=216 Participants • Data unavailable for 4 patients
|
|
New York Heart Association (NYHA) Functional Class
Class III
|
161 Participants
n=216 Participants • Data unavailable for 4 patients
|
|
New York Heart Association (NYHA) Functional Class
Class IV
|
19 Participants
n=216 Participants • Data unavailable for 4 patients
|
|
Mitral Regurgitation (MR) Etiology
Functional MR
|
106 Participants
n=218 Participants • Data unavailable for 2 patients
|
|
Mitral Regurgitation (MR) Etiology
Degenerative MR
|
85 Participants
n=218 Participants • Data unavailable for 2 patients
|
|
Mitral Regurgitation (MR) Etiology
Mixed MR
|
23 Participants
n=218 Participants • Data unavailable for 2 patients
|
|
Mitral Regurgitation (MR) Etiology
Other
|
4 Participants
n=218 Participants • Data unavailable for 2 patients
|
|
Mitral Regurgitation (MR) Severity
None/Trace (0-1+)
|
0 Participants
n=220 Participants
|
|
Mitral Regurgitation (MR) Severity
Mild (1+)
|
0 Participants
n=220 Participants
|
|
Mitral Regurgitation (MR) Severity
Mild to Moderate (2+)
|
1 Participants
n=220 Participants
|
|
Mitral Regurgitation (MR) Severity
Moderate to Severe (3+)
|
137 Participants
n=220 Participants
|
|
Mitral Regurgitation (MR) Severity
Severe (4+)
|
82 Participants
n=220 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Analysis includes patients who had an MAE or who were followed for at least 30 days. Patients may experience more than one MAE.
Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair \[TEER\] or mitral valve surgery)
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
n=216 Participants
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
Major Adverse Events (MAEs)
Composite MAE
|
9 Participants
|
|
Major Adverse Events (MAEs)
All-cause death
|
2 Participants
|
|
Major Adverse Events (MAEs)
Myocardial infarction
|
0 Participants
|
|
Major Adverse Events (MAEs)
Stroke
|
1 Participants
|
|
Major Adverse Events (MAEs)
Heart failure hospitalization
|
5 Participants
|
|
Major Adverse Events (MAEs)
Complication requiring transcatheter or surgical intervention (repeat TEER or mitral valve surgery)
|
2 Participants
|
PRIMARY outcome
Timeframe: 30 days, 12 monthsPopulation: Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.
MR severity assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+).
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
n=191 Participants
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
Mitral Regurgitation (MR) Reduction to <=2+
30 days
|
155 Participants
|
|
Mitral Regurgitation (MR) Reduction to <=2+
12 months
|
122 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 12 monthsPopulation: Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.
KCCQ is a 23-item, self-administered, validated questionnaire that quantifies physical function, symptoms, social function, self-efficacy, and quality of life for patients with heart failure. Scores range from 0 to 100 with higher scores indicating better function (100 = no symptoms, no limitations, and excellent quality of life).
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
n=107 Participants
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores
Baseline
|
45.3 Score on a scale
Standard Deviation 19.93
|
|
Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores
30 Days
|
59.1 Score on a scale
Standard Deviation 20.89
|
|
Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores
12 Months
|
71.0 Score on a scale
Standard Deviation 21.83
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 12 monthsPopulation: Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.
Patient's self-rated health on a visual analog scale (0-100 points; 0=worst health you can imagine and 100=best health you can imagine).
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
n=85 Participants
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)
Baseline
|
51.9 Score on a scale
Standard Deviation 18.16
|
|
Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)
30 Days
|
60.6 Score on a scale
Standard Deviation 17.77
|
|
Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)
12 Months
|
61.6 Score on a scale
Standard Deviation 20.21
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 12 monthsPopulation: Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.
NYHA Functional Classification is a 4-category system commonly used by physicians to assess patient heart failure symptoms based on limitations to physical activity: Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
n=220 Participants
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
New York Heart Association (NYHA) Functional Classification
Baseline · Class I
|
3 Participants
|
|
New York Heart Association (NYHA) Functional Classification
Baseline · Class II
|
33 Participants
|
|
New York Heart Association (NYHA) Functional Classification
Baseline · Class III
|
161 Participants
|
|
New York Heart Association (NYHA) Functional Classification
Baseline · Class IV
|
19 Participants
|
|
New York Heart Association (NYHA) Functional Classification
30 Days · Class I
|
29 Participants
|
|
New York Heart Association (NYHA) Functional Classification
30 Days · Class II
|
89 Participants
|
|
New York Heart Association (NYHA) Functional Classification
30 Days · Class III
|
64 Participants
|
|
New York Heart Association (NYHA) Functional Classification
30 Days · Class IV
|
1 Participants
|
|
New York Heart Association (NYHA) Functional Classification
12 Months · Class I
|
28 Participants
|
|
New York Heart Association (NYHA) Functional Classification
12 Months · Class II
|
73 Participants
|
|
New York Heart Association (NYHA) Functional Classification
12 Months · Class III
|
67 Participants
|
|
New York Heart Association (NYHA) Functional Classification
12 Months · Class IV
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 30 days, 12 monthsPopulation: Outcome data collected per standard of care at each investigative site and analyzed, if available. Analysis population includes participants with available data at one or more timepoints.
6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.
Outcome measures
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
n=119 Participants
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
6-Minute Walk Test (6MWT)
30 Days
|
292.9 meter
Standard Deviation 119.92
|
|
6-Minute Walk Test (6MWT)
Baseline
|
275.5 meter
Standard Deviation 116.16
|
|
6-Minute Walk Test (6MWT)
12 Months
|
310.2 meter
Standard Deviation 108.30
|
Adverse Events
Edwards PASCAL Transcatheter Mitral Valve Repair System
Serious adverse events
| Measure |
Edwards PASCAL Transcatheter Mitral Valve Repair System
n=220 participants at risk
Mitral valve repair with PASCAL implanted via transcatheter procedure
|
|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.45%
1/220 • Number of events 1 • 1 year
|
|
Cardiac disorders
Readmission - Cardiac (not Heart Failure)
|
11.8%
26/220 • Number of events 30 • 1 year
|
|
Cardiac disorders
Readmission - Heart Failure
|
15.9%
35/220 • Number of events 51 • 1 year
|
|
Injury, poisoning and procedural complications
Atrial Septal Defect (ASD) Closure Due to Transseptal Catheterizaton
|
0.91%
2/220 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Bleeding at Access Site
|
0.45%
1/220 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Hematoma at Access Site
|
0.45%
1/220 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Major Vascular Complication
|
0.45%
1/220 • Number of events 1 • 1 year
|
|
Product Issues
Other Device Related Event
|
1.4%
3/220 • Number of events 3 • 1 year
|
|
Product Issues
Single Leaflet Device Attachment
|
0.45%
1/220 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
New Requirement for Dialysis
|
1.8%
4/220 • Number of events 6 • 1 year
|
|
Surgical and medical procedures
Complication Requiring Transcatheter or Surgical Intervention
|
0.91%
2/220 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Mitral Valve Re-Intervention
|
1.8%
4/220 • Number of events 5 • 1 year
|
|
Surgical and medical procedures
Readmission - Non-Cardiac (Follow Up)
|
10.0%
22/220 • Number of events 30 • 1 year
|
|
Surgical and medical procedures
Unplanned Other Cardiac Surgery or Intervention (Not Mitral Valve Re-Intervention)
|
7.3%
16/220 • Number of events 27 • 1 year
|
|
Surgical and medical procedures
Unplanned Vascular Surgery or Intervention (for Bleeding or Access Site Complication)
|
0.45%
1/220 • Number of events 1 • 1 year
|
|
Vascular disorders
Life-Threatening Bleeding
|
0.45%
1/220 • Number of events 2 • 1 year
|
|
Vascular disorders
Major Bleeding Event
|
1.4%
3/220 • Number of events 3 • 1 year
|
|
Vascular disorders
Other Bleed
|
0.91%
2/220 • Number of events 2 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication or presentation of the overall registry results and/or site-specific results requires prior written approval of Edwards.
- Publication restrictions are in place
Restriction type: OTHER