Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

This study (VISTA-US) tests the safety and effectiveness of the VDyne transcatheter tricuspid valve replacement system for treating severe tricuspid regurgitation — a condition where the tricuspid valve in the right side of the heart fails to close properly, causing blood to leak backwards. This leakage forces the heart to work harder and leads to fluid buildup, fatigue, swelling, and eventually organ damage. Traditional open-heart surgery to repair or replace the tricuspid valve carries high risks in these often frail patients. The VDyne system offers a minimally invasive alternative: a new valve delivered via a catheter threaded through blood vessels, avoiding open-chest surgery. Eligible participants must be adults (18 or older) with symptomatic severe tricuspid regurgitation (NYHA class II or higher), adequately treated with heart failure medications including a diuretic, and determined to be a suitable candidate for the VDyne system by a multidisciplinary heart team and imaging review. Many exclusion criteria apply related to anatomy, heart function, infections, recent procedures, kidney or liver disease, and other serious conditions that would make the procedure too risky or unlikely to benefit the patient. Participants will receive the VDyne valve implant via catheter and be followed for clinical outcomes over 3 years. This research is important because tricuspid regurgitation is dramatically underdiagnosed and undertreated — many patients deteriorate over years without surgical options considered too risky. A safe transcatheter replacement device could offer a much-needed treatment pathway for these patients who currently have very few options.