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NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study

Join a study on heart valve treatment options.

Recruiting
21 years and older
All
Phase N/A
**NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Study** When the tricuspid valve in the heart leaks, it causes blood flow problems, making people feel tired and breathless. This study is testing a new procedure called TRAIPTA to help adults with this condition who can't have regular surgery. TRAIPTA involves placing a special loop around the heart to reduce the leak. The loop is put in place using a wire that goes through a vein in the leg. **Key Points:** - **Participants:** Must be adults aged 21 and over with tricuspid valve issues, ineligible for standard surgeries. - **Procedure & Visits:** Involves at least a 1-day hospital stay for the procedure and 4 follow-up visits in 1 year, with tests like blood tests and heart scans. - **Safety & Risks:** The study will check for safety issues 30 days after the procedure, including risks like bleeding or kidney problems. Participants will be monitored for 4 additional years for any heart issues.
Study details
    Tricuspid Valve Insufficiency

NCT06479824

National Heart, Lung, and Blood Institute (NHLBI)

7 March 2026

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