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

NCT07796659 | Recruiting

• 1 other identifier: 202202
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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 100 patients at four (4) centers in the Republic of Georgia.

Conditions

Mitral Valve Disease

Keywords

MR; FMR; Secondary MR; MVR; Mitral valve regurgitation

Outcome Measures

Primary Outcomes (2)

• Primary safety outcome

  Incidence of all-cause mortality following treatment with the MRace Implant and Delivery System

  30-days follow-up

• Primary Performance Endpoint

  Incidence of change from severe mitral regurgitation at baseline (Grade 3+ or more) to moderate or less mitral regurgitation (Grade 2+ or less) following treatment with the MRace Implant and Delivery System as evaluated by TTE

  30-days follow-up

Study Arms (1)

MRace Arm

EXPERIMENTAL

Single-arm study of MRace Implant and Delivery System to treat severe mitral regurgitation All enrolled patients will receive the study device

Device: Transcatheter mitral valve repair (MRace Implant and Delivery System)

Interventions

Transcatheter mitral valve repair (MRace Implant and Delivery System) DEVICE

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

MRace Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Greater than moderate mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
• Patient must present with an STS Score less than 10%
• High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
• New York Heart Association (NYHA) Functional Class III or IV
• Patient willing to participate in study and provide signed IRB/EC-approved informed consent
• Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits

You may not qualify if:

• Severe tricuspid regurgitation
• Severe aortic stenosis or insufficiency
• Severe mitral annulus calcification
• Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
• Implanted vena cava filter
• Femoral veins with severe angulation and calcification
• Contraindication for transesophageal echocardiography (TEE) or MDCT scan
• Active infection or endocarditis
• Previous mitral valve surgery
• Prior orthotopic heart transplantation
• Pulmonary artery systolic hypertension \> 70mmHg
• Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
• Left ventricular ejection fraction (LVEF) \< 20%
• Implant or revision of any pacing device \< 30 days prior to intervention
• Symptomatic coronary artery disease treated \< 30 days prior to study procedure

Sponsors & Collaborators

• Polares Medical SA: lead

Study Sites (4)

Israeli-Georgian Medical Research Clinic Healthycore

Tbilisi, 0112, Georgia

RECRUITING

LLC "Emergency Cardilogy Center by Acad. G. Chapidze"

Tbilisi, 0159, Georgia

RECRUITING

Ltd Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

RECRUITING

Ltd Tbilisi Heart Centre

Tbilisi, 0186, Georgia

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm registry

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: May 23, 2022
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

GE (4)