Trial Parameters
Condition Tricuspid Valve Regurgitation
Sponsor TRiCares
Study Type INTERVENTIONAL
Phase N/A
Enrollment 15
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-11
Completion 2026-03
Interventions
Transcatheter Tricuspid Valve Replacement
Brief Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Eligibility Criteria
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