TRiCares
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
Inclusion Criteria: * Adult patients * Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential) * Institutional Heart Team evaluates patient as being at increased operative risk Exclusion Criteria: * Patient in need of emergent intervention * Patient who is hemodynamically unstable * Anatomical contraindications for implantation with study device * Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
Replacement of the tricuspid valve through a transcatheter approach