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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 (DE)

NCT07757776 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-11

No results posted yet for this study

Summary

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 20 patients at 4 centers in Germany.

Conditions

  • Mitral Valve (MV) Regurgitation

Interventions

DEVICE

Transcatheter mitral valve repair (MRace Implant and Delivery System)

The MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture

Sponsors & Collaborators

  • Polares Medical SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2032-12-31
Completion
2032-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757776 on ClinicalTrials.gov