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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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Registry-Based Real-World Use Surveillance


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General
Study Status Study Pending
Application Number /
Requirement Number		 P240042 / PAS002
Date Original Protocol Accepted 05/23/2025
Date Current Protocol Accepted 10/04/2025
Study Name Registry-Based Real-World Use Surveillance
Device Name Tendyne Transcatheter Mitral Valve System
Clinical Trial Number(s) NCT03433274 
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 Registry-Based Real-World Use Surveillance. The objective of the surveillance is to assess the real-world performance of the Transcatheter Mitral Valve System.
Study Population Patients with asymptomatic severe native calcific aortic stenosis who are judged by a heart team to be appropriate for transcatheter heart valve replacement therapy.
Sample Size All consecutive severe MAC patients treated within the first 2 years following device approval or a total of 200 consecutively treated patients, whichever is greater, who are entered into the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry (enrollment period)
Key Study Endpoints The clinical data through one (1) year will be collected through the TVT Registry. The follow-up data (including all-cause mortality, stroke, mitral valve reintervention, and heart failure hospitalizations) 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 05/23/2026    
2 year report 05/23/2027    
3 year report 05/22/2028    
4 year report 05/22/2029    
5 year report 05/22/2030    


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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