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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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EHR-Based New Enrollment Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P150048 S092/ PAS001
Date Original Protocol Accepted 02/06/2026
Date Current Protocol Accepted 02/06/2026
Study Name EHR-Based New Enrollment Study
Device Name TRIFORMIS RESILIA Tricuspid Valve
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit.Adolescent A (distinctively):18 yrs<22 yrs, Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives EHR-Based New Enrollment Study. The objective of this study is to assess the real-world performance of the TRIFORMIS RESILIA Tricuspid Valve, with an emphasis on valve hemodynamic performance
Study Population Patients implanted with the TRIFORMIS RESILIA Tricuspid Valve.
Sample Size A minimum of 75 evaluable patients
Key Study Endpoints Hemodynamics (discharge, 30 days, and 1 year, at a minimum), all-cause mortality, cardiovascular mortality, all-cause readmission (30 days only), valve-related heart failure hospitalization, freedom from tricuspid valve reintervention, and major valve-related events (including valve thrombosis, endocarditis, thromboembolism, and hemorrhage).
Follow-up Visits and Length of Follow-up 5 years


EHR-Based New Enrollment Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 04/27/2026 04/24/2026 On Time
1 year report 10/27/2026    
18 month report 04/27/2027    
2 year report 10/27/2027    
3 year report 10/26/2028    
4 year report 10/26/2029    
5 year report 10/26/2030    


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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