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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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SAPIEN 3 and SAPIEN 3 Ultra Aortic THV-in-THV Surv


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General
Study Status Progress Adequate
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 Procedural: The SAPIEN 3 or SAPIEN 3 Ultra valve was implanted successfully in 99.4% of patients. One procedure was converted to open-heart surgery secondary to coronary occlusion. No aortic valve reinterventions were reported. 30-Day Adverse event rates: All-cause death: 4.8% Cardiac death: 3.5% All stroke: 2.0% Life threatening/major bleeding: 0% Myocardial Infarction: 0% New requirement for dialysis: 0.7% Transient ischemic attack (TIA): 0.7% Vascular complications: 3.9% Major vascular complication: 0.6%
Actual Number of Patients Enrolled 153 implanted with the valve
Actual Number of Sites Enrolled 100
Patient Follow-up Rate 30 Days: 86.4%; 1 year follow-up is in progress with 100 subjects pending visits
Final Effect Findings Paravalvular Leak: 30-days: > Moderate – 2.4% (2/83) 1-year: > Moderate – 0.0% (0/14) Mean gradient: Baseline: 38.9 mmHg; 30-day: 18.0 mmHg; 1-year: 20.1 mmHg KCCQ: Baseline: 40.4; 30-day: 73.1; 1-year: 70.5


SAPIEN 3 and SAPIEN 3 Ultra Aortic THV-in-THV Surv Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/09/2021 09/07/2021 On Time
2 year report 09/09/2022 08/30/2022 On Time
3 year report 09/09/2023    
4 year report 09/08/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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