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HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

Study acronym: HighFLO
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 3, 2024 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 1, 2024 to Dec 1, 2025
    • Study completion date: Feb 1, 2030 to Feb 1, 2031
    v8
  2. Enrollment target: 15 to 30
    • Primary completion date: Dec 1, 2023 to Dec 1, 2024
    • Study sites: 12 to 14
    • Study completion date: Jan 1, 2028 to Feb 1, 2030
    v7
  3. Primary completion date: Dec 1, 2022 to Dec 1, 2023v6
  4. Primary completion date: Jul 1, 2022 to Dec 1, 2022
    • Study completion date: Jul 1, 2027 to Jan 1, 2028
    • Site details revised at 1 of 12 sites
    v5
  5. Site details revised at 4 of 12 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 12
    • Study completion date: Sep 1, 2026 to Jul 1, 2027
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Trial Details
NCT Number NCT04888247
Lead Sponsor HighLife SAS
Conditions
(from sponsor)		 Mitral Regurgitation
Related terms Mitral Valve Insufficiency
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov