Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

This clinical trial is evaluating the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement System — a device that replaces the tricuspid valve in the heart without open-heart surgery. The tricuspid valve sits between the right atrium and right ventricle; when it leaks severely (a condition called tricuspid regurgitation), the heart has to work harder and the patient experiences fatigue, fluid retention, and reduced quality of life. Traditional surgical repair carries high risk in these often-frail patients, making this minimally invasive catheter-based approach an important potential option. Eligible participants are adults aged 18 or older with severe or greater tricuspid regurgitation, heart failure symptoms (NYHA Class II or higher), who have been adequately treated with medical therapy including diuretics, and whose anatomy is suitable for the device as confirmed by imaging and the Heart Team. People with unsuitable anatomy, anticoagulation intolerance, nickel or titanium allergy, severely reduced heart function, active infection, recent stroke, end-stage kidney or liver disease, or life expectancy under 12 months are among those excluded. Participants will undergo the catheter-based valve replacement procedure and be followed over time for changes in heart function, quality of life, and adverse events. This research matters because severe tricuspid regurgitation is a serious and underdiagnosed condition, and a safe, effective transcatheter treatment would provide an option for many patients currently considered too high-risk for surgery.