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

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....

Eligibility

* INCLUSION CRITERIA:
* Adults \>= 21 years
* Severe tricuspid valve regurgitation with intact tricuspid leaflets, due to annular dilation, leaflet tethering, etc.
* NYHA class III or IV congestive heart failure (symptomatic tricuspid regurgitation)
* 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
* Consents to participate, in writing, and willing to comply with all study procedures for the duration of the study

EXCLUSION CRITERIA:

* 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

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