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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 |
02/24/2025
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| 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
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| Clinical Trial Number(s) |
NCT02744677
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Descriptive
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| 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.
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| 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.
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| Sample Size |
150
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| 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
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Freedom from Death with Vital Sweep: 30-days: 100%; One-year: 100%
Device Success: 90.4% (113/125):
Single THV implanted in desired location: 99.3% (133/134)
RV-PA peak-to-peak gradient < 35 mmHg: 92.9% (118/127)
Less than moderate PR by discharge TTE: 98.5% (131/133)
Free of explant at 24 hours post-implantation: 100% (134/134)
At 1 year, THV Dysfunction Overall: 1.1% (1/88):
RVOT reintervention: 0.7% (1/134)
Moderate or greater PR: 0.0% (0/88)
Mean RVOT gradient > 40 mm/Hg: 0.0% (0/88)
Effectiveness Results:
Mean RVOT gradient via TTE: Baseline: 27.9 mmHg; 30-day: 11.8 mmHg; 1-year: 11.5 mmHg
Peak RVOT gradient via TTE: Baseline: 47.4 mmHg; 30-day: 20.9 mmHg; 1-year: 20.8 mmHg
Change in Total Pulmonary Regurgitation: 30-day: Improved: 96.6% (112/116); Stayed the same; 3.4% (4/116)
One-year: Improved: 95.2% (79/83); Stayed the same: 4.8% (4/83)
Paravalvular Regurgitation: 30-day: None: 97.5% (116/119); Trace: 0.0% (0/119); Mild: 2.5% (3/119)
One-year: None: 98.9% (87/88); Trace: 0.0% (0/88); Mild: 1.1% (1/88)
Change in Tricuspid Regurgitation:
30-day: Improved: 29.1% (34/117); Stayed the same: 59.8% (70/117); Worsened: 11.1% (13/117)
One-year: Improved: 31.8% (27/85), Stayed the same:
56.5% (48/85), Worsened: 11.8% (10/85)
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| Actual Number of Patients Enrolled |
Actual Number of Subjects Enrolled 150 total subjects enrolled. 134 subjects successfully implanted.
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| Actual Number of Sites Enrolled |
19
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| Patient Follow-up Rate |
At 30 days, 131 subjects (known status) of 134 total subjects implanted (in the 30-day window) results in a 97.8% (131/134) rate.
At 1 year, 101 subjects (known status) of 112 total subjects implanted (in the 1-year window) results in an 90.2% (101/112) rate.
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