Study to Evaluate Safety and Performance of the TRiCares Topaz Transcatheter Tricuspid Valve Replacement System in Adults with Severe Tricuspid Regurgitation

What this Trial Is About

Researchers are evaluating the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System in adults with severe tricuspid valve regurgitation who are considered at increased risk for surgery. This multi-center, prospective single arm study focuses on treating tricuspid valve regurgitation, a condition affecting heart valve function and cardiovascular health. The study is sponsored by TRiCares and aims to gather detailed safety and effectiveness data for this device. Participants will receive treatment with the TRiCares Topaz Transcatheter Tricuspid Valve Replacement System, which replaces the tricuspid valve through a minimally invasive transcatheter approach. The study has one treatment group where all participants undergo this valve replacement procedure. Researchers will monitor patients immediately after the intervention and at multiple follow-up points, including 30 days, 6 months, and annually for up to five years. During the study, participants will undergo assessments such as the six-minute walk test, evaluation of tricuspid regurgitation severity, and measurement of heart function using the New York Heart Association NYHA classification. The primary outcomes include a composite of major adverse events within 30 days post-intervention and success of the device implantation immediately after the procedure. Follow-up evaluations extend to long-term monitoring up to five years to assess ongoing heart function and patient wellbeing.

The TRICURE EU Pivotal Study