f Post-Approval Studies (PAS) Database
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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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Contuned f/u of the Premarket Cohort


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General
Study Status Study Pending
Application Number /
Requirement Number		 P230007 / PAS001
Date Original Protocol Accepted 04/01/2024
Date Current Protocol Accepted  
Study Name Contuned f/u of the Premarket Cohort
Device Name TriClip G4 System
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The objective of this trial was to evaluate the safety and effectiveness of the TriClip device in symptomatic patients with severe TR who were determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.

The study includes continued follow-up of patients enrolled under the IDE, including the TRILUMINATE pivotal trial and the Continued Access Protocol (CAP) investigation. The TRILUMINATE pivotal trial was a prospective, multicenter, randomized, controlled, clinical trial to test the superiority of the TriClip device in addition to medical therapy over medical therapy alone. The CAP began once the Randomized and Single-Arm cohorts of the pivotal trial finished enrolling. All subjects enrolled into the CAP received the TriClip device.

Study Population The study population consists of patients with symptomatic, severe tricuspid valve regurgitation whose symptoms and TR severity persist despite being optimally treated with medical therapy and who are at intermediate or greater risk for tricuspid valve surgery as determined by a heart team.

Sample Size The study will continue to follow all living patients who were enrolled under the IDE.

Key Study Endpoints Data will be collected per the study protocol and summarized descriptively, including, but not limited to, adverse event data including deaths, tricuspid valve reintervention, heart failure related hospitalizations, echocardiographic endpoints including tricuspid regurgitation severity grade, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, SF-36 score (1 and 2 years only), New York Heart Association (NYHA) classification, and 6-Minute Walk Test (6MWT) distance. KCCQ score and TR severity grade will be collected with a minimum of 75% completeness rate each year through 5 years.

Follow-up Visits and Length of Follow-up 5 years


Contuned f/u of the Premarket Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 04/01/2025    
2 year report 04/01/2026    
3 year report 04/01/2027    


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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