EXPLORE DMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation

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