Clinical Trial

HighLife Clarity Treatment of Severe Mitral Regurgitation

Study acronym: HIGHFIVE
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-11-08; most recent amendment 2025-09-09.
Status change: Withheld → Not Yet Recruiting 2025-03-04
Trial Details
NCT Number NCT06683729
Lead Sponsor HighLife SAS
Conditions Mitral Valve (MV) Regurgitation
Enrollment 240 participants
Start Date 2025-12-30
Primary Completion 2028-06 (estimated)
Study Completion 2034-06 (estimated)
Updated on ClinicalTrials.gov 2025-09-15