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The TRICURE US IDE Pivotal Study

Study acronym: TRICURE US IDE
StatusNot Yet Recruiting
PhaseNot applicable
SponsorTRiCares
Started
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Record History

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  1. Primary endpoint(s) modifiedv2 Show 9 more changesShow less
    • Phase changed: not specified → not applicable
    • Sponsor changed: [Redacted] to TRiCares
    • Trial status changed: Withheld → Not Yet Recruiting
    • Enrollment changed: None → 831
    • Trial arms changed: 0 → 3
    • Primary completion date: Sep 2031
    • Study completion date: Sep 2035
    • Start date: Oct 2026
    • Study title shortened, about 7 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
TRiCares
4 trials monitored
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Heart Disease
8,786 trials monitored
See 412 trials at risk
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.
Trial Details
NCT Number NCT07528326
Lead Sponsor TRiCares
Conditions
(from sponsor)		 Tricuspid Regurgitation (TR)
Related terms Tricuspid Valve Insufficiency
Enrollment 831 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov