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

Launched by POLARES MEDICAL SA · Oct 27, 2023

Keywords

ClinConnect Summary

The EXPLORE MRace trial is studying a new treatment for severe mitral regurgitation, which is a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. The trial aims to assess the safety and effectiveness of a device called the MRace Implant, which is designed to help repair the mitral valve. This is an early-stage study that will enroll up to 10 patients at a single center in Brazil, and participants will be followed for five years after the procedure to see how well the treatment works.

To be eligible for the trial, participants must be 18 years or older and have moderate to severe mitral regurgitation that has been confirmed by a heart test called transesophageal echocardiography (TEE). They should also have a specific heart health score indicating they are at a high surgical risk for traditional valve repair or replacement. Patients will need to agree to return for follow-up visits and provide informed consent to participate. This trial is not yet recruiting, so there will be more information available as it begins. Participants can expect to receive close monitoring and care throughout the study.

Gender

ALL

Eligibility criteria

• 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) \< 30%
• • 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 patient requiring dialysis
• • 21. Cardiogenic shock at time of enrolment
• • 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 at time of enrolment
• • 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. 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
• • 28. Emergency situations
• • 29. Company employees or their immediate family members
• • 30. Patient is under guardianship
• • 31. Patient is participating in another clinical study for which follow-up is currently ongoing