early feasibility study of the plar implant and delivery system to treat functional mitral regurgitation ( explore fmr )

Conditions: Functional Mitral Regurgitation

Summary: an early feasibility study to evaluate the safety and feasibility of the plar implant and delivery system to treat severe functional 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 up to 4 centers in north america.

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 plar 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 of the mitral valve. 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 plar implant and delivery system has been designed to overcome and mitigate some of these shortfalls.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. greater than moderate functional 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. patient is approved by an independent patient eligibility committee 6. new york heart association (nyha) functional class iii or iv 7. patient willing to participate in study and sign the irb/ec-approved informed consent 8. treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits 9. women of child-bearing potential have a negative pregnancy test 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 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 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. patient is under guardianship 31. patient is participating in another clinical study for which follow-up is currently ongoing