Clinical Trial

Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

Recruiting
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Summary
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2019-07-20; most recent amendment 2025-09-09.
Trial Details
NCT Number NCT04029363
Lead Sponsor HighLife SAS
Collaborators: ICON plc
Conditions Mitral Regurgitation
Enrollment 120 participants
Start Date 2019-05-28
Primary Completion 2026-12-15 (estimated)
Study Completion 2031-12-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-15