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The TRICURE EFS Study
Recruiting
The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study
Who can join
Ages 18 and older · All sexes
Full 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
About the study
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
What is being tested
- Transcatheter Tricuspid Valve Replacement (device)
Sponsor: TRiCares · Participants: 15 · Started: Sep 11, 2024
Contact the study team
- Esther Gerteis · Phone: +41796015318
Official record on ClinicalTrials.gov — NCT06506942
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.