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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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Continued F/U of TRISCEND II Premarket Cohort


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General
Study Status Study Pending
Application Number /
Requirement Number		 P230013 S013/ PAS001
Date Original Protocol Accepted 10/31/2025
Date Current Protocol Accepted 10/31/2025
Study Name Continued F/U of TRISCEND II Premarket Cohort
Device Name Edwards EVOQUE Tricuspid Valve Replacement System
Clinical Trial Number(s) NCT04482062  
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of all living patients who were enrolled under the IDE, including those enrolled in the continued access protocol (CAP) investigation. The objective of this study is to characterize the clinical outcomes annually through 5 years (post-randomization for the control arm and post-procedure for the device arm of the randomized cohort, the single-arm registry, and CAP cohort).
Study Population All living subjects enrolled under the IDE.
Sample Size All living subjects.
Key Study Endpoints Device deficiency, adverse events, all-cause mortality, heart failure hospitalization, non-elective tricuspid valve re-intervention (percutaneous or surgical), durable right ventricular assist device (RVAD) implantation or heart transplant, need for paracentesis, device success, echocardiographic parameters, 6-minute walk distance, New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, 36-Item Short Form Health Survey (SF-36) score, and EuroQoL 5-Dimensional Questionnaire (EQ-5D-5L) score.
Follow-up Visits and Length of Follow-up 5 years


Continued F/U of TRISCEND II Premarket Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 02/01/2026 01/30/2026 On Time
2 year report 02/01/2027    
3 year report 02/01/2028    
4 year report 02/01/2029    
5 year report 02/01/2030    


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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