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Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

Study acronym: TEERMISO
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Study completion date: Dec 30, 2025 to Dec 30, 2026v9
  2. Primary completion date: Aug 1, 2023 to Mar 1, 2024
    • Study completion date: Mar 30, 2025 to Dec 30, 2025
    • Site details revised at 1 of 2 sites
    v8
  3. Start date: Jun 1, 2022 to Jun 1, 2017
    • Site details revised at 1 of 2 sites
    v7
  4. Study completion date: Mar 30, 2024 to Mar 30, 2025v6
  5. Study completion date: Feb 28, 2024 to Mar 30, 2024
    • Collaborators revised (4)
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study completion date: Dec 1, 2023 to Feb 28, 2024v4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Primary completion date: Dec 1, 2021 to Aug 1, 2023
    • Start date: Oct 1, 2021 to Jun 1, 2022
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.
Trial Details
NCT Number NCT05090540
Lead Sponsor Centre Cardiologique du Nord
Collaborators: Campus Bio-Medico University, Henri Mondor University Hospital, Hokkaido University, University of Genova
Conditions
(from sponsor)		 Severe Mitral Valve Regurgitation (Disorder)
Related terms Mitral Valve Insufficiency
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov