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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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S3UR Real World Surveillance


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General
Study Status Study Pending
Application Number /
Requirement Number
P140031 S141/ PAS001
Date Original Protocol Accepted 09/23/2022
Date Current Protocol Accepted  
Study Name S3UR Real World Surveillance
Device Name Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
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 Comprehensive/linked/registry-based surveillance. The objective of the surveillance is to assess the real-world performance of the SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve.
Study Population The surveillance will involve all consecutive patients treated within the first 2 years that are entered into the TVT Registry (enrollment period)
Sample Size All consecutive patients treated within the first 2 years in the commercial setting that are entered into the TVT Registry.
Key Study Endpoints (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening /major bleeding, new requirement for dialysis, peri-procedural myocardial infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 2-10 year post-implantation.
Follow-up Visits and Length of Follow-up 10 years


S3UR Real World Surveillance Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 07/28/2023    
2 year report 07/28/2024    
3 year report 07/28/2025    
4 year report 07/28/2026    
5 year report 07/28/2027    
6 year report 07/28/2028    
7 year report 07/28/2029    
8 year report 07/28/2030    
9 year report 07/28/2031    


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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