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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 yrs < 12 yrs,
Adolescent: 13-18 yrs,
Transit.Adolescent A (distinctively):18 yrs<22 yrs,
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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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: 90.8% (119/131):
Single THV implanted in desired location: 99.3% (133/134)
RV-PA peak-to-peak gradient < 35 mmHg: 93.2% (124/133)
Less than moderate PR by discharge TTE: 98.5% (130/132)
Free of explant at 24 hours post-implantation: 100% (134/134)
At 1 year, THV Dysfunction Overall: 1.8% (2/111):
RVOT reintervention: 0.7% (1/134)
Moderate or greater PR: 0.9% (1/112)
Mean RVOT gradient > 40 mm/Hg: 0.0% (0/111)
Effectiveness Results:
Mean RVOT gradient via TTE: Baseline: 27.8 mmHg; 30-day: 11.8 mmHg; 1-year: 11.4 mmHg
Peak RVOT gradient via TTE: Baseline: 47.3 mmHg; 30-day: 20.9 mmHg; 1-year: 20.6 mmHg
Change in Total Pulmonary Regurgitation: 30-day: Improved: 96.6% (113/117); Stayed the same; 3.4% (4/117)
One-year: Improved: 95.3% (101/106); Stayed the same: 4.7% (5/106)
Paravalvular Regurgitation: 30-day: None: 97.5% (116/119); Trace: 0.0% (0/119); Mild: 2.5% (3/119)
One-year: None: 99.1% (111/112); Trace: 0.0% (0/112); Mild: 0.9% (1/112)
Change in Tricuspid Regurgitation:
30-day: Improved: 28.6% (34/119); Stayed the same: 60.5% (72/119); Worsened: 10.9% (13/119)
One-year: Improved: 31.5% (34/108), Stayed the same:
58.3% (63/108), Worsened: 10.2% (11/108)
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| Actual Number of Patients 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, 132 subjects (known patient status) of 134 total subjects implanted results in a 98.5% (132/134) rate.
At 1 year, 126 subjects (known patient status) of 134 total subjects implanted results in a 94.0% (136/134) rate.
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