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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200015 / PAS002 |
| Date Original Protocol Accepted |
04/16/2021
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| Date Current Protocol Accepted |
|
| Study Name |
SAPIEN 3 Pulmonic New Enrollment Study-COMPASSION
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| Device Name |
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, multi-center, single-arm new enrollment study. The objective of the study is to monitor the device performance and clinical outcomes of the SAPIEN 3 THV System with Commander Delivery System in the real world for the approved indication.
|
| Study Population |
Pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic valve in the pulmonic position with greater than or equal to moderate regurgitation and/or a mean RVOT gradient of greater than or equal to 35 mmHg.
|
| Sample Size |
150
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| Key Study Endpoints |
Device success, THV dysfunction, THV hemodynamic function, and New York Heart Association (NYHA) classification.
|
| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
At 1 year:
Device Success: 90.5% (57/63)
Single THV implanted in desired location: 97.2% (70/72)
RV-PA peak-to-peak gradient < 35 mmHg: 92.4% (61/66)
Less than moderate PR by discharge TTE: 100% (67/67)
Free of explant at 24 hours post-implantation: 100% (72/72)
Effectiveness results:
Mean RVOT gradient: Baseline: 28.1 mmHg; 30-day: 11.7 mmHg; 1-year: 11.6 mmHg
Peak RVOT gradient: Baseline: 46.8 mmHg; 30-day: 20.5 mmHg; 1-year: 20.4 mmHg
Paravalvular Regurgitation:
30-day: None – 94.6% (53/56), Mild – 5.4% (3/56)
1-year: None – 92.3% (12/13), Mild – 7.7% (1/13)
Total pulmonary regurgitation:
30-Day: Improved – 96.2% (51/53), Stayed the same – 3.8% (2/53)
1-Year: Improved – 91.7% (11/12), Stayed the same – 8.3% (1/12)
Tricuspid Regurgitation:
30-Day: Improved – 24.1% (13/54), Stayed the same – 57.4% (31/54), Worsened – 18.5% (10/54)
1-Year: Improved – 38.5% (5/13), Stayed the same – 38.5% (5/13), Worsened – 23.1% (3/13)
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| Actual Number of Patients Enrolled |
78 total subjects enrolled. Implant procedure attempted in 72 subjects and successfully implanted in 70 subjects.
|
| Actual Number of Sites Enrolled |
16
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| Patient Follow-up Rate |
At 30 days, 69 subjects (with known status) of 78 total subjects (in the 30-day window) results in a 69/78 (88%) 30-day follow-up rate at this time.
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