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

NCT07517588 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-08

No results posted yet for this study

Summary

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

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

MR-ace Implant and Delivery System

This study device uses a transcatheter procedure through your leg veins to place the MRace implant and cover the posterior leaflet of your own mitral valve.

Sponsors & Collaborators

  • Polares Medical SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-31
Completion
2031-12-31
FDA Device
Yes

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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 NCT07517588 on ClinicalTrials.gov