TTVR Early Feasibility Study

This study is an early feasibility study of a new device for replacing the tricuspid valve — one of the four valves in the heart — using a catheter-based approach rather than open-heart surgery. The tricuspid valve controls blood flow between the right side of the heart, and when it leaks badly (tricuspid regurgitation), the heart has to work much harder, leading to symptoms like severe fatigue, leg swelling, and shortness of breath. Until recently, treating this valve was mainly possible through surgery, which carries high risks in many patients. The Intrepid TTVR system is threaded through a large vein in the leg and into the heart, where an artificial valve is deployed. This trial is testing whether the approach is safe and feasible in patients who are too high-risk for conventional surgery. Participants are followed for long-term outcomes. You may be eligible if: - You have severe symptomatic tricuspid regurgitation confirmed by echocardiogram - You have NYHA Class II or greater heart failure symptoms - Your Heart Team has determined you are at intermediate or high risk for conventional tricuspid surgery - You are anatomically suitable for the delivery system - You are the legal minimum age for consent in your country You may NOT be eligible if: - Your life expectancy is less than 24 months due to non-cardiac causes - You have a mass or clot in the heart or large veins - You have implanted venous stents that would block catheter access - Your right ventricle (heart's pumping chamber) is severely dysfunctional - Your left heart ejection fraction is below 30% - You have carcinoid disease affecting the tricuspid valve Talk to your doctor to see if this trial is right for you.