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The TRICURE US IDE Pivotal Study
Recruiting
TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Patient is ≥ 18 years of age * Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy * Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team Exclusion Criteria: * Patient has a tricuspid device currently in place * Patient has anatomical contraindications * Patient is in need of urgent surgery * Patient has a left ventricular ejection fraction of \< 25% * Patient has life expectancy of \< 1 year
About the study
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
What is being tested
- TRiCares Topaz TTVR System (device)
- Edwards EVOQUE TTVR System (device)
- TRiCares Topaz TTVR System (device)
Sponsor: TRiCares · Participants: 831 · Started: Jul 8, 2026
Contact the study team
- Stephanie Cihlar · Phone: 763-227-7833
Official record on ClinicalTrials.gov — NCT07528326
Locations in the U.S.
| Georgia | Piedmont Heart Institute, Atlanta |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.