|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P200015 / PAS002 |
Date Original Protocol Accepted |
04/16/2021
|
Date Current Protocol Accepted |
 
|
Study Name |
SAPIEN 3 Pulmonic New Enrollment Study-COMPASSION
|
Device Name |
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
|
Clinical Trial Number(s) |
NCT02744677
|
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
|
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
|
Key Study Endpoints |
Device success, THV dysfunction, THV hemodynamic function, and New York Heart Association (NYHA) classification.
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Follow-up Visits and Length of Follow-up |
5 years
|
Interim or Final Data Summary |
Interim Results |
Safety Results At 1 year: Device Success: 88.4% (84/95) Single THV implanted in desired location: 97.3% (109/112) RV-PA peak-to-peak gradient < 35 mmHg: 92.5% (98/106) Less than moderate PR by discharge TTE: 99% (96/97) Free of explant at 24 hours post-implantation: 100% (113/113)
Effectiveness results: Mean RVOT gradient: Baseline: 28.1 mmHg; 30-day: 11.7 mmHg; 1-year: 11.1 mmHg Peak RVOT gradient: Baseline: 47.3 mmHg; 30-day: 20.7 mmHg; 1-year: 20.2 mmHg Paravalvular Regurgitation: 30-day: None – 96.3% (79/82), Mild – 3.7% (3/82) 1-year: None – 97.7% (43/44), Mild – 2.3% (1/44) Total pulmonary regurgitation: 30-Day: Improved – 96.3% (77/80), Stayed the same – 3.8% (3/80) 1-Year: Improved – 92.9% (39/42), Stayed the same – 7.1% (3/42) Tricuspid Regurgitation: 30-Day: Improved – 25.9% (21/81), Stayed the same – 59.3% (48/81), Worsened – 14.8% (12/81) 1-Year: Improved – 25.6% (11/43), Stayed the same – 58.1% (25/43), Worsened – 16.3% (7/43)
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Actual Number of Patients Enrolled |
126 total subjects enrolled. 110 subjects successfully implanted.
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Actual Number of Sites Enrolled |
19
|
Patient Follow-up Rate |
At 30 days, 101 subjects (with known status) of 113 total subjects (in the 30-day window) results in a 101/113 (89%) 30-day follow-up rate at this time.
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