TRAIPTA Procedure for Tricuspid Regurgitation

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byRobert J Lederman, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

No Placebo Group

Trial Summary

What is the purpose of this trial?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....

Eligibility Criteria

This trial is for adults over 21 with tricuspid valve regurgitation who can't have standard surgery. They'll undergo screening tests, including heart function assessments, before the procedure.

Inclusion Criteria

Cardiac size suitable for available TRAIPTA study devices according to NHLBI Core Lab analysis of cardiac CTA indicating a TRAIPTA extracardiac perimeter of 25-40cm

Concordance of the study central clinical eligibility committee

I am 21 years old or older.

+3 more

Exclusion Criteria

My heart's left ventricle is weak, with an ejection fraction less than 30%.

Known hypersensitivity to study device materials (for example, nickel)

Pregnancy or intent to become pregnant prior to completion of all 12-month protocol follow-up procedures

+12 more

Participant Groups

The TRAIPTA procedure is being tested to reduce leakage in the tricuspid heart valve. It involves placing a loop device around the heart via a vein in the leg while under sedation or anesthesia.

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)