MRace Implant: A first look at fixing the mitral valve to reduce regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early feasibility study will enroll up to 100 adults with at least moderate-to-severe mitral regurgitation who are high surgical risk. It uses a transcatheter approach to implant a posterior leaflet augmentation prosthesis via a transvenous/transseptal route, aiming to improve valve coaptation. The primary goal is to assess safety and feasibility, with follow-up extending to five years to gather preliminary performance data. The study is conducted at four centers in Georgia and Israel and is structured as a registry without a control group. Patients will receive regular post-procedure evaluations to monitor MR reduction and valve function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years of age or older
2. Greater than moderate mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
3. Patient must present with an STS Score less than 10%
4. 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
5. New York Heart Association (NYHA) Functional Class III or IV
6. Patient willing to participate in study and provide signed IRB/EC-approved informed consent
7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Severe tricuspid regurgitation
2. Severe aortic stenosis or insufficiency
3. Severe mitral annulus calcification
4. Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
5. Implanted vena cava filter
6. Femoral veins with severe angulation and calcification
7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan
8. Active infection or endocarditis
9. Previous mitral valve surgery
10. Prior orthotopic heart transplantation
11. Pulmonary artery systolic hypertension \> 70mmHg
12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
13. Left ventricular ejection fraction (LVEF) \< 20%
14. Implant or revision of any pacing device \< 30 days prior to intervention
15. Symptomatic coronary artery disease treated \< 30 days prior to study procedure
16. Myocardial infarction requiring intervention \< 30 days prior to study procedure
17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
18. Active peptic ulcer or upper gastrointestinal bleeding \< 90 days prior to study procedure
19. Stroke \< 180 days prior to study procedure
20. Severe renal insufficiency (creatinine \> 3.0 mg/dL) or Subject requiring dialysis
21. Cardiogenic shock at time of enrollment
22. Hemodynamic instability requiring inotropic support or mechanical heart assistance
23. Concurrent medical condition with a life expectancy of less than 2 years
24. Pregnancy or breastfeeding at time of enrollment
25. History of bleeding diathesis or coagulopathy or leukopenia (WBC \< 3,000 mcL) or acute anemia (Hb \< 9 g/dL) or thrombocytopenia (platelets \< 50,000 cells mcL)
26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
27. Emergency situations
28. Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments
29. Company employees or their immediate family members
30. Subject is under guardianship
31. Subject is participating in another clinical study for which follow-up is currently ongoing.

Where it's running

• Israeli-Georgian Medical Research Clinic Healthycore
  Tbilisi, Georgia Recruiting
• LLC "Emergency Cardilogy Center by Acad. G. Chapidze"
  Tbilisi, Georgia Recruiting
• Ltd Tbilisi Heart and Vascular Clinic
  Tbilisi, Georgia Recruiting
• Ltd Tbilisi Heart Centre
  Tbilisi, Georgia Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using the CoolCryo System to treat Atrial Fibrillation during Mitral Valve Surgery

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• Left atrial shunt to help after mitral valve surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.