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EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)

Study acronym: EXPLORE-MRace
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
See other at-risk trials from Polares Medical SA

Record History

  1. Primary completion pushed from Dec 31, 2026 to Dec 31, 2027v2 Show 4 more changesShow less
    • Recruitment opened
    • Start date: Jun 1, 2026 to Sep 1, 2026
    • Trial sites expanded: 0 → 3 locations
    • Study completion pushed from Dec 31, 2031 to Dec 31, 2032
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are: Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve? Participants will: Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey
Trial Details
NCT Number NCT07517588
Lead Sponsor Polares Medical SA
Conditions
(from sponsor)		 Mitral Regurgitation
Related terms Mitral Valve Insufficiency
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov