Safety and Effectiveness Study of the VDyne Transcatheter Tricuspid Valve Replacement System for Treating Severe Tricuspid Valve Regurgitation in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement System for treating tricuspid regurgitation, a heart valve disorder. The study aims to gather data to support the devices approval under Conformit Europenne CE marking. This clinical investigation is led by VDyne, Inc. and focuses on adults with severe tricuspid valve problems who are candidates for this treatment. Participants will receive treatment using the VDyne System, a device designed to replace the tricuspid valve via a minimally invasive procedure. The study includes one treatment group using this system. Key assessments will occur from baseline to one month after the procedure, with extended follow-up up to one year to track device-related major adverse events, valve function, quality of life, symptom status, and physical capacity. Throughout the study, participants will undergo imaging evaluations, functional tests like the 6-minute walk test, and quality of life questionnaires. Researchers will monitor safety and effectiveness at multiple time points, including 30 days, 3 months, 6 months, and one year after the procedure. The total duration of participation varies, with ongoing assessments to ensure comprehensive data collection and patient monitoring.

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