Post-Approval Studies (PAS) Database

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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Intermediate Risk Indication Real-World Use Surv

General
Study Status	Study Pending
Application Number / Requirement Number	P140031 S162/ PAS001
Date Original Protocol Accepted	05/23/2024
Date Current Protocol Accepted
Study Name	Intermediate Risk Indication Real-World Use Surv
Device Name	Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems
Clinical Trial Number(s)	NCT03193801
General Study Protocol Parameters
Study Design	Comprehensive/Linked/RegistryBased Surveillance
Data Source	External Registry
Comparison Group	Historical Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	The objective of the surveillance is to assess the real-world performance of the SAPIEN 3 platform for the mitral valve-in-valve intermediate-risk indication.
Study Population	Adults
Sample Size	All patients entered into the TVT Registry database with a failing surgical mitral valve (stenosed, insufficient, or combined) who are judged by a heart team to be at intermediate risk for open surgical therapy and treated with the SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra RESILIA THV Systems within the first 3 years after the date of PMA approval or a total of 1,000 treated patients, whichever is greater. Data collection will continue for underrepresented racial and ethnic groups until each group has enrolled the following minimum number of patients: 150 Hispanic, 150 Black/African American, 100 Asian, 50 American Indian/Alaskan Native, 25 Native Hawaiian/Pacific Islander.
Key Study Endpoints	Intra-Procedural: Device implanted successfully; 30 Days and 1 year: All-cause mortality, all stroke, life threatening/major bleeding, new requirement for dialysis, myocardial infarction, mitral valve reintervention, TIA, vascular complications, 6-minute walk distance, Quality of life (KCCQ), change in NYHA functional class from baseline, mitral valve hemodynamics; Annually years 2-10: all-cause mortality, all stroke, mitral valve reintervention.
Follow-up Visits and Length of Follow-up	10 years

Intermediate Risk Indication Real-World Use Surv Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	05/23/2025
2 year report	05/23/2026
3 year report	05/23/2027
4 year report	05/22/2028
5 year report	05/22/2029

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background