Mitral Valve Disease
Conditions
Keywords
MR, FMR, Secondary MR, MVR, Mitral valve regurgitation
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.
Detailed description
Percutaneous approaches to treat MR promise to provide a sufficient reduction in MR without the risks typically associated with open heart surgery. Furthermore there is an unmet clinical need for patients with severe MR who are refused or denied surgery due to high risk. Percutaneous therapy provides a novel alternative treatment option for these patients with the aim of reducing morbidity and mortality over and above current medical therapy. The Polares Medical MRace Implant and Delivery System is a catheter-based technology designed to permanently implant a prosthesis using a transvenous / transseptal approach to augment the posterior mitral valve leaflet and improve coaptation with the anterior leaflet. Approved edge-to-edge repair has already been shown to be a viable alternative for high risk MR patients. However treatment with these devices is limited to specific anatomies and often requires multiple devices which increases clinical risk, adds to procedural time, and can result in residual MR. The MRace Implant and Delivery System has been designed to overcome and mitigate some of these shortfalls
Interventions
The MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
Sponsors
Polares Medical SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm registry
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety outcome | 30-days follow-up | Incidence of all-cause mortality following treatment with the MRace Implant and Delivery System |
| Primary Performance Endpoint | 30-days follow-up | 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 |
Countries
Georgia
Outcome results
None listed