|
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 Endpoints: All-cause death: 4.3% (30 Days); 19.8% (1Y) Cardiac death: 2.6% (30 Days); 7.6% (1Y) All strokes: 1.7% (30 Days); 2.3% (1Y) Aortic Valve reintervention: 0.2% (30 Days); 0.2% (1Y) Life threatening/major bleeding: 1.2% (30 Days); 4.7% (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)
Effectiveness Endpoints: 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
|
Actual Number of Patients Enrolled |
430 implanted with the valve
|
Actual Number of Sites Enrolled |
215
|
Patient Follow-up Rate |
30 Days: 95.4% (412/432); 1 year: 63.7% (275/432) 30 Days: 5 lost to follow-up; 15 missed visits; 1 year: 14 lost to follow-up; 72 missed visits; follow-up is in progress with 71 subjects pending visits
|