EXPLORE DMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
EXPLORE DMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and
 Delivery System to treat severe degenerative 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.
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 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 PLAR Implant and Delivery System has been designed to overcome and
 mitigate some of these shortfalls.
Inclusion Criteria:

 1. 18 years of age or older

 2. Greater than moderate degenerative 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