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An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 17, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Dec 2027 to Dec 2030
    • Site contacts updated at 8 of 10 sites
    v6
  2. Enrollment target: 15 to 30v5 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 8 to 10
    • Interventions: HighLife Transcatheter Mitral Valve Replacment (Device) to Transcatheter Mitral Valve Replacement (Device)
    • Eligibility criteria shortened, about 95 words
    • Study description expanded, about 306 words
    • Secondary endpoints expanded, about 2 words
  3. Primary completion date: Dec 2022 to Dec 2024v4
  4. Phase: Early Phase 1 to Not applicablev3 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Apr 2021 to Dec 2022
    • Study completion date: Apr 2026 to Dec 2027
    • Start date changed from estimate of Apr 2020 to Jul 14, 2020
    • Study arms: 0 to 1
  5. Start date: Sep 2019 to Apr 2020
    • Primary completion date: Oct 2020 to Apr 2021
    • Study completion date: Oct 2025 to Apr 2026
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
Trial Details
NCT Number NCT04029337
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