Early Feasibility Study of the TRiCares Topaz Transfemoral Tricuspid Valve Replacement System Evaluating Safety and Performance in Adults with Severe Tricuspid Valve Regurgitation

What this Trial Is About

Researchers are conducting a multi-center, prospective study to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System. This study focuses on adults with severe tricuspid valve regurgitation who are considered at increased risk for traditional surgery. The study aims to provide information on how well this new transcatheter valve replacement device works and its safety in this patient population. Participants will receive treatment with the TRiCares Topaz Transfemoral Transcatheter Tricuspid Valve Replacement System. This device replaces the tricuspid valve using a less invasive transcatheter approach, avoiding open heart surgery. The study is designed as a single-group trial where all participants receive the investigational valve replacement. During the study, participants will be monitored for major adverse events and device success immediately after the procedure and within 30 days. Follow-up assessments include a six-minute walk test, evaluation of tricuspid regurgitation severity, and New York Heart Association functional class at 30 days, 6 months, and annually for up to five years. These evaluations help track both the safety and performance of the device over time.

The TRICURE EFS Study