NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study
NCT Number: NCT06479824
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tricuspid Valve Insufficiency
Interventions: DEVICE: TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-10
Completion Date: 2030-09-01
Locations: Medstar WHC, Washington, District of Columbia, 20010, United States|Emory University, Atlanta, Georgia, 30308, United States|St. Francis Hospital and Heart Center, Roslyn, New York, 11576, United States|Carilion Medical Center, Roanoke, Virginia, 24014, United States

Summary:
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....

Primary Outcome Measures: Safety of TRAIPTA procedure, Safety is measured as a composite of freedom from major adverse cardiovascular events (MACE) assessed at 30 days after the TRAIPTA procedure, including all of the following:-All-cause Mortality-Stroke (disabling and non-disabling)-Device-related pulmonary thromboembolism (symptomatic)-TRAIPTA-related coronary compression requiring coronary revascularization or post-procedure relief of TRAIPTA-compression-Pericardial tamponade. Note that insertion of a pericardial drain and pericardial effusion requiring drainage is an expected part of the TRAIPTA procedure, and does not contribute to the primary safety endpoint.-Major cardiac structural related complications including cardiac surgery related to the device.-Major access site and vascular complications-Acute kidney injury requiring new renal replacement therapy.-Bleeding (major or worse) according to MVARC, 30 days