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The TRICURE First in Human Trial

Study acronym: TRICURE
StatusActive, Not Recruiting
PhaseNot applicable
SponsorTRiCares
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 15, 2024 to Mar 1, 2025
    • Site details revised at 11 of 11 sites
    v11
  2. Primary completion date: Sep 15, 2024 to Dec 15, 2024v10
  3. Study title shortened, about 6 wordsv9
  4. Primary completion date: Apr 15, 2024 to Sep 15, 2024v8
  5. Primary completion date: Oct 15, 2023 to Apr 15, 2024
    • Study completion date: Mar 15, 2028 to May 15, 2029
    • Site details revised at 3 of 11 sites
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 4 to 11v6
  2. Primary completion date: Mar 15, 2023 to Oct 15, 2023v5
  3. Study sites: 2 to 4v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites revised (2)
    v3
  5. Start date: Mar 15, 2022 to Jul 15, 2022
    • Study sites: 1 to 2
    • Primary completion date: Dec 15, 2022 to Mar 15, 2023
    • Study completion date: Dec 15, 2027 to Mar 15, 2028
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Trial Details
NCT Number NCT05126030
Lead Sponsor TRiCares
Conditions
(from sponsor)		 Tricuspid Regurgitation
Related terms Tricuspid Valve Insufficiency
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov