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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Registry-Based Real-World Use Surveillance

General
Study Status	Study Pending
Application Number / Requirement Number	P250019 / PAS002
Date Original Protocol Accepted	02/19/2026
Date Current Protocol Accepted	02/19/2026
Study Name	Registry-Based Real-World Use Surveillance
Device Name	SAPIEN M3 Transcatheter Mitral Valve Replacement System
Clinical Trial Number(s)	NCT04153292
General Study Protocol Parameters
Study Design	Active Surveillance
Data Source	External Registry
Comparison Group	Historical Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	Registry-Based Real-World Use Surveillance. The objective of the surveillance is to assess the real-world performance of the SAPIEN M3 system.
Study Population	Patients treated for symptomatic moderate-to-severe or severe mitral regurgitation (MR) (Cohort A) and patients treated for symptomatic mitral valve dysfunction associated with mitral annular calcification (MAC) (Cohort B) that are entered into the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry.
Sample Size	Cohort A will involve all consecutive patients treated in the first 2 years following device approval or a total of 500 consecutively treated patients, whichever is greater (Cohort A enrollment period). Cohort B will involve all consecutive patients treated in the first 2 years following device approval or a total of 200 consecutively treated patients, whichever is greater (Cohort B enrollment period). Data collection in Cohort A will continue for under-enrolled racial and ethnic groups until each group has enrolled a minimum number of patients as specified: Black/African American, 50; Asian, 50, American Indian/Alaskan Native, 25, Native Hawaiian/Pacific Islander, 25; and Hispanic or Latino ethnicity, 50.
Key Study Endpoints	The clinical data through one (1) year will be collected through the TVT Registry. The follow-up data (including all-cause death, stroke, mitral valve reintervention, and heart failure rehospitalizations) from year 2 through year 5 post-procedure will be obtained through linking the TVT Registry data with the Centers for Medicare and Medicaid Services (CMS) claims database.
Follow-up Visits and Length of Follow-up	5 years

Registry-Based Real-World Use Surveillance Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	12/22/2026
2 year report	12/22/2027
3 year report	12/22/2028
4 year report	12/22/2029
5 year report	12/22/2030

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