NCT06113354 EXPLORE MRace (BR): Early Feasibility Experience of Posterior Leaflet Restoration to Reduce Mitral Regurgitation Using the MRace Implant
| NCT ID | NCT06113354 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Polares Medical SA |
| Condition | Mitral Valve Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2032-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-04-08 with a primary completion date of 2032-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 10 patients at one (1) center in Brazil.
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
Contact & Investigator
Robin Eckert
STUDY DIRECTOR
Polares Medical
Frequently Asked Questions
Who can join the NCT06113354 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06113354 currently recruiting?
Yes, NCT06113354 is actively recruiting participants. Contact the research team at korosz@polaresmedical.com for enrollment information.
Where is the NCT06113354 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil, São Paulo, Brazil.
Who is sponsoring the NCT06113354 clinical trial?
NCT06113354 is sponsored by Polares Medical SA. The principal investigator is Robin Eckert at Polares Medical. The trial plans to enroll 10 participants.