EFS of the CardioMech MVRS

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Enrollment increased: 25 → 35 participants
    • Eligibility criteria expanded, about 8 words
    • Site details revised at 12 of 12 sites
  2. Site details revised at 1 of 12 sitesv13
  3. Study sites: 11 to 12v12
  4. Trial status: Suspended to Recruiting
    • Study sites: 9 to 11
    v11
  5. Trial status: Recruiting to Suspended Sponsor's reason: Pending device design changes.
    • Primary completion date: Dec 2025 to Sep 2026
    • Study completion date: Dec 2030 to Sep 2031
    • Site details revised at 9 of 9 sites
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 8 to 9v9
  2. Enrollment target: 10 to 25v8 Show 4 more changesShow less
    • Primary completion date: Sep 2024 to Dec 2025
    • Study completion date: Jun 2029 to Dec 2030
    • Eligibility criteria shortened, about 9 words
    • Site contacts updated at 8 of 8 sites
  3. Primary completion date: Jun 2024 to Sep 2024
    • Site contacts updated at 1 of 8 sites
    v7
  4. Site details revised at 3 of 8 sitesv6
  5. Trial status: Active, Not Recruiting to Recruitingv5 Show 4 more changesShow less
    • Enrollment target: 15 to 10
    • Study sites: 6 to 8
    • Primary completion date: Apr 2024 to Jun 2024
    • Study completion date: Apr 2029 to Jun 2029
  6. Primary completion date: Dec 2022 to Apr 2024
    • Study completion date: Dec 2026 to Apr 2029
    v4
  7. Primary completion date: Dec 2021 to Dec 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 6
    • Start date changed from estimate of Aug 2021 to Jul 27, 2021
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Trial Details
NCT Number NCT04820764
Lead Sponsor CardioMech AS
Conditions
(from sponsor)		 Mitral Regurgitation
Related terms Mitral Valve Insufficiency
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov