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

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Jun 27, 2024

Keywords

ClinConnect Summary

The TRAIPTA study is testing a new procedure for people with a heart condition called tricuspid valve regurgitation, where a valve in the heart leaks and can cause symptoms like breathlessness and fatigue. This study aims to see how effective the trans-atrial intra-pericardial tricuspid annuloplasty (TRAIPTA) procedure is for adults over 21 who have severe leakage and are not suitable for standard surgery. Participants will undergo tests to check their heart health before spending at least one day in the hospital for the procedure, which involves placing a special device around the heart to help reduce the leak.

To be eligible for the study, participants must have severe tricuspid valve regurgitation and experience significant symptoms, but they should not have had previous heart surgery or certain other conditions that could complicate the procedure. After the TRAIPTA procedure, participants will have regular follow-up visits over the next year to monitor their recovery and heart function. The study is not yet recruiting participants, but it is designed to help improve treatment options for people struggling with this heart condition.

Gender

ALL

Eligibility criteria

• * 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