|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P220003 / PAS001 |
| Date Original Protocol Accepted |
09/14/2022
|
| 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
|
| 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
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Roll-In: 91; Randomized: 300; Registry: 98
|
| Actual Number of Sites Enrolled |
Roll-In: 51; Randomized: 54 sites; Registry: 35
|
| Patient Follow-up Rate |
Roll-In (visits completed / eligible for visit): 2-year: 62/67 (92%)
Randomized: PASCAL: 2-year: 128/151 (85%); MitraClip: 2-year: 77/81 (95%)
Registry: 2-year: 54/68 (79%)
|
| Final Safety Findings |
Roll-in safety results at 2-years:
Composite MAEs: 25.9%
All-cause mortality: 21.8%
Non-elective mitral valve re-intervention: 1.1%
Stroke: 3.5%
Transient ischemic attack (TIA): 2.2%
Major vascular events: 1.1%
New Need for Renal Replacement Therapy: 2.6%
Residual atrial septal defect: 50%
Randomized safety results at 2-years:
PASCAL:
Composite MAEs: 26.9%
All-cause mortality: 20.3%
Non-elective mitral valve re-intervention: 2.1%
Stroke: 5.3%
Transient ischemic attack (TIA): 1.5%
Major vascular events: 0%
New Need for Renal Replacement Therapy: 1.1%
Residual atrial septal defect: 40.7%
MitraClip:
Composite MAEs: 16.1%
All-cause mortality: 13.8%
Non-elective mitral valve re-intervention: 2.1%
Stroke: 1.1%
Transient ischemic attack (TIA): 1.1%
Major vascular events: 0%
New Need for Renal Replacement Therapy: 1.1%
Residual atrial septal defect: 58.3%
Registry:
Composite MAEs: 30.9%
All-cause mortality: 24%
Non-elective mitral valve re-intervention: 1%
Stroke: 5.1%
Transient ischemic attack (TIA): 1%
Major vascular events: 1%
New Need for Renal Replacement Therapy: 3.5%
Residual atrial septal defect: 70.4%
|
| Final Effect Findings |
Mitral Regurgitation (Greater than Moderate-Severe):
Roll-in: 98.8% (Baseline); 6.6% (2Y);
Randomized: PASCAL - 97.4% (Baseline); 5.0% (2Y); MitraClip - 100% (Baseline); 6.9% (2Y);
Registry: 99% (Baseline); 8.3% (2Y)
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 (16.1 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).
|
