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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P220003 / PAS001 |
| Date Original Protocol Accepted |
09/14/2022
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| Date Current Protocol Accepted |
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| Study Name |
Continued Follow-up of the CLASP III Trial Cohort
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| Device Name |
PASCAL Precision Transcatheter Valve Repair System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of all living subjects who were enrolled in the pivotal cohort under the IDE. The objective of this study is to characterize the clinical outcomes annually through 5 years post-procedure.
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| Study Population |
All living subjects who were enrolled in the IDE pivotal cohort.
|
| Sample Size |
All living subjects.
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| Key Study Endpoints |
Major adverse events (MAEs), all-cause mortality, non-elective mitral valve re-intervention (either percutaneous or surgical), stroke, transient ischemic attack (TIA), major vascular events, renal complications, residual atrial septal defect (ASD), MR grade, 6-minute walk test (6MWT) distance, and quality of life (QoL) measures.
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Roll-In: 91; Randomized: 300; Registry: 98
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| Actual Number of Sites Enrolled |
Roll-In: 51; Randomized: 54 sites; Registry: 35
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| Patient Follow-up Rate |
Roll-In (visits completed / eligible for visit): 30 day: 88/89 (99%); 1 year: 74/79 (94%)
Randomized:
PASCAL: 30 day: 194/197 (98.5%); 1 year: 162/177 (91.5%)
MitraClip: 30 day: 92/92 (100%); 1 year: 83/88 (94%)
Registry: 30 day: 93/96 (97%); 1 year: 77/84 (92%)
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| Final Safety Findings |
Roll-in:
Composite MAEs - 8.8% (30 Days); 15.5% (1Y)
All-cause mortality: 2.2% (30 Days); 8.8% (1Y)
Non-elective mitral valve re-intervention: 1.1% (30 Days); 1.1% (1Y)
Stroke: 2.2% (30 Days); 2.2% (1Y)
Transient ischemic attack (TIA): 1.1% (30 Days); 2.2% (1Y)
Major vascular events: 1.1% (30 Days); 1.1% (1Y)
New Need for Renal Replacement Therapy: 0% (30 Days); 1.2% (1Y)
Residual atrial septal defect: 77.6% (30 Days); 61.8% (1Y)
Randomized: PASCAL
Composite MAEs: 4.6% (30 Days); 15.3% (1Y)
All-cause mortality: 1% (30 Days); 8.5% (1Y)
Non-elective mitral valve re-intervention: 1.5% (30 Days); 2.1% (1Y)
Stroke: 0.5% (30 Days); 2.2% (1Y)
Transient ischemic attack (TIA): 0.5% (30 Days); 0.5% (1Y)
Major vascular events: 0% (30 Days); 0% (1Y)
New Need for Renal Replacement Therapy: 0% (30 Days); 1.1% (1Y)
Residual atrial septal defect: 70.4% (30 Days); 54.1% (1Y)
Randomized: MitraClip
Composite MAEs - 5.4% (30 Days); 11.7% (1Y)
All-cause mortality: 3.2% (30 Days); 8.4% (1Y)
Non-elective mitral valve re-intervention: 1.1% (30 Days); 2.1% (1Y)
Stroke: 1.1% (30 Days); 1.1% (1Y)
Transient ischemic attack (TIA): 0% (30 Days); 1.1% (1Y)
Major vascular events: 0% (30 Days); 0% (1Y)
New Need for Renal Replacement Therapy: 0% (30 Days); 1.1% (1Y)
Residual atrial septal defect: 71.4% (30 Days); 56.5% (1Y)
Registry:
Composite MAEs - 11.2% (30 Days); 16.5% (1Y)
All-cause mortality: 2% (30 Days); 10.2% (1Y)
Non-elective mitral valve re-intervention: 1% (30 Days); 1% (1Y)
Stroke: 1% (30 Days); 2.1% (1Y)
Transient ischemic attack (TIA): 1% (30 Days); 1% (1Y)
Major vascular events: 1% (30 Days); 1% (1Y)
New Need for Renal Replacement Therapy: 1% (30 Days); 2.2% (1Y)
Residual atrial septal defect: 81.5% (30 Days); 60% (1Y)
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| Final Effect Findings |
Mitral Regurgitation (Greater than Moderate-Severe):
Roll-in: 98.8% (Baseline); 2.4% (30 Days); 4.5% (1Y);
Randomized: PASCAL - 97.4% (Baseline); 1.6% (30 Days); 4.2% (1Y); MitraClip - 100% (Baseline); 4.3% (30 Days); 6.3% (1Y);
Registry: 99% (Baseline); 9% (30 Days); 7% (1Y)
6-minute walk test (6MWD):
Roll-in: The median improvement in 6MWD compared to baseline was 29.9 m at 30 days and 23.0 m at 1 year.
Randomized (PASCAL): The median 6MWD distance increased by 16.7 m at 30 days and 13.4 m at 1 year.
Randomized (MitraClip): The median 6MWD distance increased by 29.5 m at 30 days and 22.2 m at 1 year.
Registry: The median 6MWD distance increased by 17.5 m
at 30 days and 20.0 m at 1 year.
KCCQ (Overall Score):
Roll-in: An increase in the median score was observed at 30 days (18.5 points) and 1 year (21.6 points).
Randomized (PASCAL): An increase in the median score was observed at 30 days (13.5 points) and 1 year (12.5 points).
Randomized (MitraClip): An increase in the median score was observed at 30 days (16.1 points) and 1 year (12.3 points).
Registry: An increase in the median score was observed at 30 days (13.1 points) and 1 year (16.1 points).
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