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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-SAPIEN 3 Aortic Valve-in-Valve Comp Surv


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General
Study Status Progress Adequate
Application Number P140031 S028/ PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-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)

TIA

Vascular complications

*endpoints not available at discharge



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

KCCQ



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


OSB Lead-SAPIEN 3 Aortic Valve-in-Valve Comp Surv Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/04/2017 12/05/2017 Overdue/Received
one year report 06/05/2018    
18 month report 12/04/2018    
two year report 06/05/2019    
three year report 06/04/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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