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A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (AU)

Study acronym: ACCESS-MR (AU)
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather 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 15 patients at 1 center in Australia
Trial Details
NCT Number NCT07757698
Lead Sponsor Polares Medical SA
Conditions
(from sponsor)		 Mitral Valve (MV) Regurgitation
Related terms Gastroesophageal Reflux, Mitral Valve Insufficiency
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov