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Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Mar 15, 2025 to Dec 15, 2026
    • Study completion date: Jun 15, 2030 to Dec 15, 2031
    • Site details revised at 1 of 50 sites
    v16
  2. Primary completion date: Mar 15, 2024 to Mar 15, 2025
    • Study sites: 42 to 50
    • Study completion date: Jun 15, 2029 to Jun 15, 2030
    v15
  3. Study sites: 40 to 42
    • Primary completion date: Jan 2024 to Mar 15, 2024
    • Study completion date: Mar 2029 to Jun 15, 2029
    v14
  4. Enrollment target: 50 to 120
    • Primary completion date: Sep 2023 to Jan 2024
    • Study completion date: Oct 2027 to Mar 2029
    • Study title revised
    v13
  5. Primary completion date: Sep 2022 to Sep 2023
    • Site details revised at 6 of 40 sites
    • Collaborator revised
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 39 to 40
    • Primary completion date: May 2022 to Sep 2022
    • Study completion date: May 2027 to Oct 2027
    • Study arms: 0 to 1
    v11
  2. Study sites: 38 to 39v10
  3. Study sites: 32 to 38
    • Primary completion date: Jan 2022 to May 2022
    • Study completion date: Jul 2025 to May 2027
    v9
  4. Primary completion date: Jul 2021 to Jan 2022v8
  5. Study sites: 23 to 32v7
  6. Study sites: 12 to 23v6
  7. Primary completion date: Jul 2020 to Jul 2021v5
  8. Study sites: 9 to 12v4
  9. Study sites: 5 to 9v3
  10. Study sites: 1 to 5
    • Collaborators expanded, about 2 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
Trial Details
NCT Number NCT04029363
Lead Sponsor HighLife SAS
Collaborators: ICON plc
Conditions
(from sponsor)		 Mitral Regurgitation
Related terms Mitral Valve Insufficiency
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov