|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S112/ PAS001 |
| Date Original Protocol Accepted |
09/09/2020
|
| Date Current Protocol Accepted |
09/09/2020
|
| 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
|
| 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 Endpoints:
All-cause death: 4.5% (30 Days); 18.9% (1Y)
Cardiac death: 2.6% (30 Days); 7.6% (1Y)
All strokes: 1.7% (30 Days); 2.5% (1Y)
Aortic Valve reintervention: 0.2% (30 Days); 0.2% (1Y)
Life threatening/major bleeding: 1.5% (30 Days); 4.2% (1Y)
Myocardial infarction: 0.5% (30 Days); N/A (1Y)
New requirement for dialysis: 0.5% (30 Days); 0.5% (1Y)
TIA: 0.2% (30 Days); 0.2% (1Y)
Vascular Complications: 4.0% (30 Days); 4.0% (1Y)
Major vascular complications: 0.7% (30 Days); 0.7% (1Y)
Minor vascular complication: 3.3% (30 Days); 3.3% (1Y)
Paravalvular Leak: 30-days: >= Moderate – 1.4% (4/283) 1-year: >= Moderate – 0.8% (1/125)
KCCQ: Baseline: 37.1; 30-day: 73.9; 1-year: 78.6;
Mean Gradient: Baseline: 39.8mmHg; 30-day: 16.4mmHg; 1-year: 15.5mmHg
Effectiveness Endpoints:
Paravalvular Leak:
30-days: > Moderate – 1.4% (4/283)
1-year: > Moderate – 0.6% (1/168)
KCCQ: Baseline: 37.0; 30-day: 73.7; 1-year: 79.4; Mean Gradient: Baseline: 39.7mmHg; 30-day: 16.4mmHg; 1-year: 15.5mmHg
|
| Actual Number of Patients Enrolled |
434 attempted; 432 implanted with the valve
|
| Actual Number of Sites Enrolled |
216
|
| Patient Follow-up Rate |
30 Days: 96.1% (417/434); 1 year: 81.1% (352/434)
30 Days: 5 lost to follow-up; 12 missed visits
1 year: 17 lost to follow-up; 65 missed visits
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