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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S112/ PAS001 |
| Date Original Protocol Accepted |
09/09/2020
|
| Date Current Protocol Accepted |
|
| Study Name |
SAPIEN 3 and SAPIEN 3 Ultra Aortic THV-in-THV Surv
|
| Device Name |
EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Characterize long-term clinical outcomes for the SAPIEN 3 and SAPIEN 3 Ultra THV Systems in patients with a failing aortic transcatheter bioprosthetic valve after PMA approval through the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) registry-based surveillance.
|
| Study Population |
All patients entered into the TVT Registry database and treated with the SAPIEN 3 or SAPIEN 3 Ultra System for the first 3 years after PMA approval will be included as part of this registry-based post-approval surveillance.
|
| Sample Size |
All consecutive patients treated within the first 3 years after the PMA approval that are entered into the TVT Registry (enrollment period).
|
| Key Study Endpoints |
For aortic THV-in-THV patients, the surveillance is monitoring the following outcomes:
Procedural: Device implanted successfully
30 Days: Myocardial infarction
30 Days, 12 months, and annually for 10 years: all-cause mortality, all stroke, and valve reintervention
30 Days & 1 year: TIA, life-threatening/major bleeding, vascular complications, new requirement for dialysis, KCCQ, mean gradient, and paravalvular leak
|
| Follow-up Visits and Length of Follow-up |
10 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
Procedural: The SAPIEN 3 or SAPIEN 3 Ultra valve was implanted successfully in 98.5% of patients. 2 procedures were converted to open-heart surgery secondary to coronary occlusion.
Safety Endpoints:
All-cause death: 4.8% (30 Days); 21.2% (1Y)
Cardiac death: 2.9% (30 Days); 7.7% (1Y)
All strokes: 1.3% (30 Days); 2.1% (1Y)
Aortic Valve reintervention: 0.3% (30 Days); 0.3% (1Y)
Life threatening/major bleeding: 1% (30 Days); 4.1% (1Y)
Myocardial infarction: 0.6% (30 Days); N/A (1Y)
New requirement for dialysis: 0.3% (30 Days); 0.3% (1Y)
TIA: 0.3% (30 Days); 0.3% (1Y)
Vascular Complications: 3.1% (30 Days); 3.1% (1Y)
Major vascular complications: 0.3% (30 Days); 0.3% (1Y)
Minor vascular complication: 2.8% (30 Days); 2.8% (1Y)
|
| Actual Number of Patients Enrolled |
323 implanted with the valve
|
| Actual Number of Sites Enrolled |
179
|
| Patient Follow-up Rate |
30 Days: 91.7% (298/325); 1 year: 45.2% (147/325)
30 Days: 3 lost to follow-up; 24 missed visits; 1 year: 6 lost to follow-up; 65 missed visits; follow-up is in progress with 107 subjects pending visits
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| Final Effect Findings |
Paravalvular Leak:
30-days: > Moderate – 1.5% (3/201)
1-year: > Moderate – 0.0% (0/55)
KCCQ: Baseline: 37.0; 30-day: 74; 1-year: 78.6;
Mean Gradient: Baseline: 39.8mmHg; 30-day: 16.6mmHg; 1-year: 16.7mmHg
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