No phaseRecruitingAge-related condition
The TRICURE US IDE Pivotal Study
TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study
- Sponsor
- TRiCares (Industry)
- Enrollment
- 831 planned
- Conditions
- Tricuspid Regurgitation (TR)
- Interventions
- TRiCares Topaz TTVR System; Edwards EVOQUE TTVR System; TRiCares Topaz TTVR System
- Ages
- adults, older adults
- Registry
- NCT07528326
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Rate of Major Adverse Events (MAE)
- Composite Endpoint
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered