Evaluating Safety and Effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement System for Treating Severe Tricuspid Regurgitation

What this Trial Is About

Researchers are evaluating the safety and clinical effects of the VDyne Transcatheter Tricuspid Valve Replacement System for treating people with symptomatic severe tricuspid regurgitation, a heart valve disorder. This study aims to assess how well the device works and its safety profile in improving symptoms and heart function in affected patients. The study involves implanting the VDyne system, which includes a bioprosthetic tricuspid valve and delivery tools, via a transfemoral approach while the heart is beating. The valve can be repositioned or retrieved during the procedure if needed. There is one treatment group receiving this device, and the procedure is guided by imaging techniques without the use of cardiopulmonary bypass. Participants will be monitored from the time of implant through one year after the procedure. Researchers will assess major adverse events, changes in valve function, symptom status, exercise capacity, and quality of life at various timepoints up to one year. Safety and effectiveness will be evaluated through imaging, clinical assessments, and questionnaires. The study starts with screening, implantation, and includes follow-up visits for ongoing evaluation.

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