Clinical Trial

The TRICURE US IDE Pivotal Study

Study acronym: TRICURE US IDE
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 6 changes
critical Trial status changed: Withheld → Not Yet Recruiting 2026-05-06
critical Phase changed: not specified -> not applicable 2026-05-06
critical Primary endpoint(s) modified 2026-05-06
notable Enrollment changed: None -> 831 2026-05-06
notable Sponsor changed: [Redacted] -> TRiCares 2026-05-06
minor Trial arms changed: 0 -> 3 2026-05-06
Trial Details
NCT Number NCT07528326
Lead Sponsor TRiCares
Conditions Tricuspid Regurgitation (TR)
Enrollment 831 participants
Start Date 2026-10
Primary Completion 2031-09 (estimated)
Study Completion 2035-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-05