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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 Aortic Valve-in-Valve Comp Surv

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Study Status Progress Adequate
Application Number P140031 S028/ PAS001
Date Current Protocol Accepted  
Study Name SAPIEN 3 Aortic Valve-in-Valve Comp Surv
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Comprehensive- Linked/Registry Based Surveillance.

The purpose of this Surveillance Plan is to utilize the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry to monitor long term durability, safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve in patients with a failed surgical bioprosthetic aortic valve for 2 years following device approval. Follow-up of these patients will be linked to the Centers for Medicare and Medicaid Services (CMS) database for long-term surveillance through 5 years post implantation.

This is a new enrollment study.
Study Population Description Patients with symptomatic heart disease due to a failed surgical bioprosthetic aortic valve (stenosed, insufficient or combined) who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
Sample Size Enrollment will consist of all patients with SAPIEN 3 transcatheter heart valve in the STS/ACC TVT Registry for the 2 years following device approval (i.e. from June 5, 2017 to June 4, 2019). All aortic transcatheter SAPIEN 3 Valve in Surgical Valve patients who have the procedure date in the period of June 5, 2017 to June 4, 2019 will be included in the analysis.
Data Collection TVT-Captured Safety Endpoints at intra-procedure:
Device Implanted Successfully
TVT-Captured Safety Endpoints at discharge, 30 days and 12 months:
All-cause mortality
All stroke
Life threatening/major bleeding complications*
New requirement of dialysis
Peri-procedural myocardial Infarction
Repeated procedure for valve-related dysfunction (surgical or interventional therapy)
Vascular complications
*endpoints not available at discharge

TVT-Captured Effectiveness Endpoints (30 days and 12 months):

CMS-Captured Safety Endpoints (year 2 to 5):
All-cause mortality
All Stroke
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Follow-up Visits and Length of Follow-up 5 years post-implantation
Interim or Final Data Summary
Interim Safety Information At discharge, the rate of all-cause death was 2.6%. The Kaplan-Meier rate of all-cause death was 3.4% through 30 days and 14.5% through 1 year. Adjudicated strokes were reported as twenty-one events at discharge, twenty-five events through 30 days, and thirty-one events through 1 year. Adjudicated aortic valve reinterventions were reported in four, seven, and eleven patients through discharge, 30 days and 1 year, respectively.
Actual Number of Patients Enrolled 1875 aortic valve-in-valve patients were enrolled in the TVT registry between June 5, 2017 through June 4, 2019.
Actual Number of Sites Enrolled A total of 410 sites were enrolled (*based on database closed on February 29, 2020)
Patient Follow-up Rate 91% at 30 days and 73% at 1 year, among patients with known visit status.
(*Patients with follow-up data (numerator) include those with follow-up completed or deaths prior to visit; patients with known visit status (denominator) include those with follow-up completed, with missed visit, death prior to visit, withdrawal and lost to follow-up.)

Study Strengths & Weaknesses Strength: This study uses real-world data collected through the national STS/ACC TVT Registry to assess the safety and effectiveness of SAPIEN 3 Transcatheter Heart Valve in patients with a failed surgical bioprosthetic aortic valve.
Limitation: Results summarized are interim safety data only. Data for effectiveness endpoints will be posted at a later date (December 2024).

SAPIEN 3 Aortic Valve-in-Valve Comp Surv Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 12/04/2017 12/05/2017 Overdue/Received
1 year report 06/05/2018 06/04/2018 On Time
18 month report 12/04/2018 11/30/2018 On Time
2 year report 06/05/2019 06/05/2019 On Time
3 year report 06/04/2020 06/02/2020 On Time
4 year report 06/04/2021 06/02/2021 On Time
5 year report 06/04/2022 05/26/2022 On Time
6 year report 06/04/2023    

Contact Us

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

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