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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 |
|
| Study Name |
Continued Follow-up of the CLASP III Trial Cohort
|
| Device Name |
PASCAL Precision Transcatheter Valve Repair System
|
| Clinical Trial Number(s) |
NCT03706833
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
|
| 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.
|
| Study Population |
All living subjects who were enrolled in the IDE pivotal cohort.
|
| Sample Size |
All living subjects.
|
| 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.
|
| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Pascal Roll-in safety results at 3-years:
Composite MAEs: 34.2%
All-cause mortality: 29.7%
Cardiovascular death: 19.5%
Non-elective mitral valve re-intervention: 1.1%
Stroke: 6.4%
Transient ischemic attack (TIA): 3.3%
Severe Bleeding: 20.2%
Major vascular events: 1.1%
New Need for Renal Replacement Therapy: 4.1%
Residual atrial septal defect: 48.3%
Randomized safety results at 3-years:
PASCAL:
Composite MAEs: 36.2%
All-cause mortality: 28.1%
Cardiovascular death: 19.8%
Non-elective mitral valve re-intervention: 2.1%
Stroke: 6.8%
Transient ischemic attack (TIA): 1.5%
Severe Bleeding: 15.6%
Major vascular events: 0%
New Need for Renal Replacement Therapy: 1.9%
Residual atrial septal defect: 56.8%
MitraClip:
Composite MAEs: 25.1%
All-cause mortality: 21.1%
Cardiovascular death: 16.5%
Non-elective mitral valve re-intervention: 2.1%
Stroke: 2.4%
Transient ischemic attack (TIA): 1.1%
Severe Bleeding: 10.5%
Major vascular events: 0%
New Need for Renal Replacement Therapy: 1.1%
Residual atrial septal defect: 42.9%
Pascal Registry safety results at 3-years:
Composite MAEs: 39.5%
All-cause mortality: 31.5%
Cardiovascular death: 23.8%
Non-elective mitral valve re-intervention: 1%
Stroke: 6.8%
Transient ischemic attack (TIA): 1%
Severe Bleeding: 16.3%
Major vascular events: 1%
New Need for Renal Replacement Therapy: 5.1%
Residual atrial septal defect: 68.2%
Effectiveness Results:
Mitral Regurgitation (Greater than Moderate-Severe):
Roll-in: 98.8% (Baseline); 8.9% (3Y);
Randomized: PASCAL - 97.4% (Baseline); 4.2% (3Y); MitraClip - 100% (Baseline); 1.7% (3Y);
Registry: 99% (Baseline); 4.8% (3Y)
6-minute walk test (6MWD):
Roll-in: The median improvement in 6MWD compared to baseline was 23.0 m at 1 year.
Randomized (PASCAL): The median 6MWD distance increased by 15.9 m at 1 year.
Randomized (MitraClip): The median 6MWD distance increased by 22.2 m at 1 year.
Registry: The median 6MWD distance increased by 7.3 m
at 1 year.
KCCQ (Overall Score):
Roll-in: An increase in the median score was observed at 2 years (19.3 points).
Randomized (PASCAL): An increase in the median score was observed at 2 years (15.8 points).
Randomized (MitraClip): An increase in the median score was observed at 2 years (13.7 points).
Registry: An increase in the median score was observed at 2 years (10.7 points).
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| 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+deaths / subjects enrolled): 3-year: 77/91 (85%)
Randomized: PASCAL: 3-year: 170/199 (85%); MitraClip: 3-year: 90/95 (95%)
Registry: 3-year: 79/98 (81%)
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