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

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Conditions studied: Tricuspid Valve Insufficiency

In brief

Background: Tricuspid valve regurgitation is a disease where one of the heart valves leaks. The leak affects blood flow. People with this disease may feel breathless and lack energy; they may need to stay in the hospital when fluid builds up in the body. The tricuspid is the most difficult valve to repair with surgery. Researchers want to try a new procedure called trans-atrial intra-pericardial tricuspid annuloplasty (TRAIPTA). Objective: To test TRAIPTA in people with tricuspid valve regurgitation. Eligibility: Adults aged 21 years and over with tricuspid valve regurgitation. They must not be eligible for standard surgical repair. Design: Participants will be screened. They will have tests of their heart function; these will include blood tests, imaging scans, and a 6-minute walking test. Participants will enter the hospital for at least 1 day. The TRAIPTA procedure will be done under sedation or general anesthesia. The TRAIPTA study device is a loop that will be placed around the heart like a belt. It acts like a lasso to reduce leakage of the heart valve. Doctors will put the device in place by inserting a wire through a vein in the leg; they will thread the device up to the heart through the vein. The wire will be removed, but the TRAIPTA device will remain in place. Participants will have follow-up visits 4 times in 1 year after the procedure. These visits will include physical exams, blood tests, imaging scans, and other tests of heart function. Researchers will contact participants or their doctors for heart test results for another 4 years....

Key facts

Study ID: NCT06479824
Run by: National Heart, Lung, and Blood Institute (NHLBI)
People needed: 60
Starts: 2025-08-19
Expected to finish: 2030-09-01
Last updated by the study team: 2026-06-17

Who can join

Age: 21 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Prior cardiac surgery, which may preclude pericardial access, or known pericardial adhesions
Prior coronary artery stent in the atrioventricular groove
Severe mitral valve regurgitation assessed by echo
Left ventricular systolic dysfunction, LVEF < 0.30
Right atrial pacemaker lead if it might preclude trans-atrial access for TRAIPTA
Eligible for commercially-available transcatheter tricuspid valve replacement
Eligible for commercially-available tricuspid edge-to-edge repair (TTEER). Recurrent or persistent symptomatic tricuspid regurgitation despite TTEER is not excluded.
Having transcatheter heart valve implants at risk of compression by TRAIPTA based on anatomic location on pre-procedure CT
Severe pulmonary artery hypertension, pulmonary artery systolic pressure >=60 mm Hg
Severe baseline renal excretory dysfunction, eGFR<30mL/min/1.73m\^2 unless on renal replacement therapy
Evidence of thrombus in left atrial appendage on baseline CTA
Known hypersensitivity to study device materials (for example, nickel)
Acute coronary syndrome, myocardial infarction, or percutaneous coronary intervention within 30 days
Requiring other structural heart intervention or coronary revascularization procedure in next 3 months
Pregnancy or intent to become pregnant prior to completion of all 12-month protocol follow-up procedures

Where it is running

Emory University — Atlanta, Georgia, United States
St. Francis Hospital and Heart Center — Roslyn, New York, United States

Full record on ClinicalTrials.gov

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