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EXPLORE MRace (BR): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant

Study acronym: EXPLORE MRace
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 years 8 months later Mar 2025 → Dec 2032
See other at-risk trials from Polares Medical SA

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 1 to 2v4
  2. Primary completion pushed from Mar 2025 to Dec 2032v3 Show 5 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Dec 2023 to Apr 8, 2024
    • Study completion pushed from Dec 2029 to Dec 2032
    • Site details revised
    • Study title expanded, about 1 word
  3. Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.
Trial Details
NCT Number NCT06113354
Lead Sponsor Polares Medical SA
Collaborators: Polares Medical, Inc.
Conditions
(from sponsor)		 Mitral Valve Disease
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov