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HighLife Clarity Treatment of Severe Mitral Regurgitation

Study acronym: HIGHFIVE
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Jun 2025 to Dec 30, 2025
    • Study completion date: Jun 2033 to Jun 2034
    v3
  2. Lead sponsor: [Redacted] to HighLife SASv2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Jun 2028
    • Study completion date: Jun 2033
    • Start date: Jun 2025
    • Study title shortened, about 6 words
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of the study is to evaluate the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-to-severe or severe mitral regurgitation (MR) who, by assessment of the local Heart Team, are unsuitable for treatment with approved transcatheter repair (sub-optimal results to complex or prohibitive edge-to-edge repair) or surgical mitral valve intervention according to guidelines.
Trial Details
NCT Number NCT06683729
Lead Sponsor HighLife SAS
Conditions
(from sponsor)		 Mitral Valve (MV) Regurgitation
Related terms Gastroesophageal Reflux
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov