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

NCT06113354 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-13

No results posted yet for this study

Summary

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.

Conditions

  • Mitral Valve Disease

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 Other Names: TMVr

Sponsors & Collaborators

  • Polares Medical, Inc.

    collaborator UNKNOWN

  • Polares Medical SA

    lead INDUSTRY

Principal Investigators

  • Roberto deFilippo · Polares Medical

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2025-03-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

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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 NCT06113354 on ClinicalTrials.gov