Clinical Trial

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

Recruiting
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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.
Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-07-20; most recent amendment 2025-03-12.
Status change: Not Yet Recruiting → Recruiting 2022-10-21
Trial Details
NCT Number NCT04029337
Lead Sponsor HighLife SAS
Conditions Mitral Regurgitation
Enrollment 30 participants
Start Date 2020-07-14
Primary Completion 2025-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-17