[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414672":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":31,"responsibleParty":33,"collaborators":35,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":31,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":31,"enrollmentInfo":48,"targetDuration":31,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":31,"overallStatus":57,"whyStopped":31,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":31},{"fullName":5,"class":6},"Polares Medical SA","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-arm study of PLAR Implant and Delivery System to treat severe mitral regurgitation","EXPERIMENTAL","All enrolled patients will receive the study device",[13],"Device: Transcatheter mitral valve repair (PLAR Implant and Delivery System)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Transcatheter mitral valve repair (PLAR Implant and Delivery System)","The PLAR Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture",[9],[21],"TMVr",[23],{"name":24,"affiliation":25,"role":26},"Laura A Brenton","Polares Medical","STUDY_DIRECTOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","+1 313 919 8044",null,"lbrenton@polaresmedical.com",{"type":34,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[36],{"name":37,"class":38},"Polares Medical, Inc.","UNKNOWN","100414672","explore-dmr-early-feasibility-study-of-the-plar-implant-and-delivery-system-to-treat-degenerative-mitral-regurgitation-100414672",false,"NCT04679662","EXPLORE DMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation","Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation (EXPLORE DMR)","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Greater than moderate degenerative mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure\n3. Patient must present with an STS Score less than 10%\n4. 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\n5. New York Heart Association (NYHA) Functional Class III or IV\n6. Patient willing to participate in study and provide signed IRB\u002FEC-approved informed consent\n7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Severe tricuspid regurgitation\n2. Severe aortic stenosis or insufficiency\n3. Severe mitral annulus calcification\n4. Diseased mitral anterior leaflet such as flail \u002F prolapse\u002F heavy calcification\n5. Implanted vena cava filter\n6. Femoral veins with severe angulation and calcification\n7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan\n8. Active infection or endocarditis\n9. Previous mitral valve surgery\n10. Prior orthotopic heart transplantation\n11. Pulmonary artery systolic hypertension \\> 70mmHg\n12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus\n13. Left ventricular ejection fraction (LVEF) \\\u003C 30%\n14. Implant or revision of any pacing device \\\u003C 30 days prior to intervention\n15. Symptomatic coronary artery disease treated \\\u003C 30 days prior to study procedure\n16. Myocardial infarction requiring intervention \\\u003C 30 days prior to study procedure\n17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis\n18. Active peptic ulcer or upper gastrointestinal bleeding \\\u003C 90 days prior to study procedure\n19. Stroke \\\u003C 180 days prior to study procedure\n20. Severe renal insufficiency (creatinine \\> 3.0 mg\u002FdL) or patient requiring dialysis\n21. Cardiogenic shock at time of enrolment\n22. Hemodynamic instability requiring inotropic support or mechanical heart assistance\n23. Concurrent medical condition with a life expectancy of less than 2 years\n24. Pregnancy at time of enrolment\n25. History of bleeding diathesis or coagulopathy or leukopenia (WBC \\\u003C 3,000 mcL) or acute anemia (Hb \\\u003C 9 g\u002FdL) or thrombocytopenia (platelets \\\u003C 50,000 cells mcL)\n26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated\n27. Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial\u002Fprocedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments\n28. Emergency situations\n29. Company employees or their immediate family members\n30. Patient is under guardianship\n31. Patient is participating in another clinical study for which follow-up is currently ongoing","ALL","18 Years",{"count":49,"type":50},10,"ESTIMATED","INTERVENTIONAL",[53],"NA","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.",[56],"Degenerative Mitral Valve Disease","NOT_YET_RECRUITING","2020-12-21",{"date":60,"type":61},"2020-12-22","ACTUAL",{"date":63,"type":50},"2021-03",{"date":65,"type":50},"2026-12",{"name":5,"class":6}]