[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506253":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":168,"collaborators":170,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":181,"sex":182,"minAge":183,"maxAge":20,"enrollmentInfo":184,"targetDuration":20,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":197,"whyStopped":20,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},{"fullName":5,"class":6},"P+F Products + Features GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Arm","EXPERIMENTAL","This is a prospective, non-randomized, single-arm, international, multicenter, clinical study designed to evaluate the safety, efficacy, and performance of the P\\&F MUNICH TMVR System in a population of patients with moderate to severe symptomatic Mitral Regurgitation.",[13],"Device: MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","MUNICH TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM","The replacement valve consists of a self-expanding, tri-leaflet, dry bovine -pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The key characteristics of Munich valve are:\n\n* Nitinol stent frame\n* Bovine pericardium\n* Polyester skirt\n* Anchoring system allows anchoring the frame to the annulus\n* Hooks are used to reduce the mobility of the native leaflets and decrease risk of embolization.\n\nThe Munich TMVR system design proposed for this clinical investigation represents a significant evolution from previous TMVR designs:\n\n* Transfemoral \u002F transseptal access\n* Self-expanding\n* Dry pericardium (can be pre-loaded)\n* No anchors\n* 27 Fr delivery catheter (\n* Sizes: 40\u002F48\u002F55mm\n* Height 30 mm The valve is available in 3 sizes with a 30mm profile and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Katharina Kiss, MD","CEO, Products & Features","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Monica E Tocchi, MPH, PhD","CONTACT","9176841700","m.tocchi@meditrial.net",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Monica Tocchi, MD","M.Tocchi@meditrial.net",[36,54,65,76,85,101,115,127,143,154],{"facility":37,"status":20,"city":38,"state":20,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fundación Favaloro","Buenos Aires","C1093","Argentina","AR",{"type":43,"coordinates":44},"Point",[45,46],-58.37723,-34.61315,{"lat":46,"lon":45},[49,52],{"name":50,"role":29,"phone":20,"phoneExt":20,"email":51},"Oscar Mendiz, MD","omendiz@ffavaloro.org",{"name":50,"role":53,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":55,"status":20,"city":38,"state":20,"zip":56,"country":40,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Hospital Italiano De Buenos Aires","C1199ABB",{"type":43,"coordinates":58},[45,46],{"lat":46,"lon":45},[61,64],{"name":62,"role":29,"phone":20,"phoneExt":20,"email":63},"Carla Agatiello, MD","carla.agatiello@hospitalitaliano.org.ar",{"name":62,"role":53,"phone":20,"phoneExt":20,"email":20},{"facility":66,"status":20,"city":38,"state":20,"zip":67,"country":40,"countryCode":41,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Hospital César Milstein","C1221",{"type":43,"coordinates":69},[45,46],{"lat":46,"lon":45},[72,75],{"name":73,"role":29,"phone":20,"phoneExt":20,"email":74},"Miguel Payaslian, MD","mopian@yahoo.com.ar",{"name":73,"role":53,"phone":20,"phoneExt":20,"email":20},{"facility":77,"status":20,"city":38,"state":20,"zip":78,"country":40,"countryCode":41,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"Hospital Fernandez\u002FSanatorio Milstein","C1425AGP",{"type":43,"coordinates":80},[45,46],{"lat":46,"lon":45},[83,84],{"name":73,"role":29,"phone":20,"phoneExt":20,"email":74},{"name":73,"role":53,"phone":20,"phoneExt":20,"email":20},{"facility":86,"status":20,"city":87,"state":20,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Instituto Estadual De Cardiologia Aloysio De Castro","Rio de Janeiro","22261-010","Brazil","BR",{"type":43,"coordinates":92},[93,94],-43.18223,-22.90642,{"lat":94,"lon":93},[97,100],{"name":98,"role":29,"phone":20,"phoneExt":20,"email":99},"Marcio Jose Montenegro Da Costa, MD","marciojmontenegro@gmail.com",{"name":98,"role":53,"phone":20,"phoneExt":20,"email":20},{"facility":102,"status":20,"city":103,"state":20,"zip":104,"country":89,"countryCode":90,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Instituto Dante Pazzanese De Cardiologia","São Paulo","04012-909",{"type":43,"coordinates":106},[107,108],-46.63611,-23.5475,{"lat":108,"lon":107},[111,114],{"name":112,"role":29,"phone":20,"phoneExt":20,"email":113},"Dimytri Siqueira, MD","dimytrisiqueira@gmail.com",{"name":112,"role":53,"phone":20,"phoneExt":20,"email":20},{"facility":116,"status":20,"city":103,"state":20,"zip":117,"country":89,"countryCode":90,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"Instituto Do Coração (InCor) De São Paulo","05403-900",{"type":43,"coordinates":119},[107,108],{"lat":108,"lon":107},[122,125],{"name":123,"role":29,"phone":20,"phoneExt":20,"email":124},"Alexandre Abizaid, MD","aabizaid@uol.com.br",{"name":126,"role":53,"phone":20,"phoneExt":20,"email":20},"Alexandre Abizaid",{"facility":128,"status":20,"city":129,"state":20,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Hospital Del Torax De Santiago","Santiago","7500691","Chile","CL",{"type":43,"coordinates":134},[135,136],-70.64827,-33.45694,{"lat":136,"lon":135},[139,142],{"name":140,"role":29,"phone":20,"phoneExt":20,"email":141},"Christian Dauvergne, MD","cdauvergnem@yahoo.com",{"name":140,"role":53,"phone":20,"phoneExt":20,"email":20},{"facility":144,"status":20,"city":129,"state":20,"zip":145,"country":131,"countryCode":132,"cosmosGeoPoint":146,"geoPoint":148,"contacts":149},"Hospital Dr Sotero Del Rio De Santiago","8150215",{"type":43,"coordinates":147},[135,136],{"lat":136,"lon":135},[150,153],{"name":151,"role":29,"phone":20,"phoneExt":20,"email":152},"Martín Valdebenito, MD","mvaldet@gmail.com",{"name":151,"role":53,"phone":20,"phoneExt":20,"email":20},{"facility":155,"status":20,"city":156,"state":20,"zip":157,"country":131,"countryCode":132,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Hospital Las Higueras - Talcahuano","Talcahuano","4270940",{"type":43,"coordinates":159},[160,161],-73.11684,-36.72494,{"lat":161,"lon":160},[164,167],{"name":165,"role":29,"phone":20,"phoneExt":20,"email":166},"Osvaldo Perez, MD","osperez2000@gmail.com",{"name":165,"role":53,"phone":20,"phoneExt":20,"email":20},{"type":169,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[171],{"name":172,"class":6},"Meditrial USA Inc.","100506253","munich-transcatheter-mitral-valve-safety-and-effectiveness-100506253",false,"NCT05871983","Munich Transcatheter Mitral Valve Safety and Effectiveness","Clinical Evaluation of Safety and Effectiveness of the Munich Transcatheter Mitral Valve Replacement (TMVR) System","MUSE","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Moderate or severe mitral regurgitation (\\> 3+)\n\n   1. For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml\n   2. For Secondary MR: EROA \\> 30 mm2 or regurgitant volume \\> 45ml (i.e., MR moderate or severe by ASE criteria)\n3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV\n4. Subject is under guideline directed medical therapy for at least one month\n5. Subject is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty and disability\n6. Subject meets the anatomical criteria for Munich TMVR System\n7. Patient is willing to participate in the study and provides signed informed consent.\n\nExclusion Criteria:\n\nGeneral Conditions\n\n1. Subject who is currently participating in an investigational study, other than this study\n2. Subjects allergic to bovine tissue\n3. Subjects with uncontrolled hypotension\n4. Hemodynamic instability\n5. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated and has an allergy to Nitinol alloys\n6. Intolerance to antiplatelet, anticoagulant or thrombolytic medications\n7. Bleeding diathesis or hypercoagulable state\n8. Active peptic ulcer or active gastrointestinal bleeding\n9. Pulmonary artery systolic pressure \\>70 mmHg\n10. Renal insufficiency\n11. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n12. Subject with hepatic insufficiency\n13. Subject has a co-morbid illness that may result in a life expectancy of less than one year\n14. Active infection that requires antibiotic therapy\n15. Subject is pregnant, breastfeeding or intend to become pregnant within one year, and female subjects in childbearing age NOT using a highly effective method of contraception with a failure rate of less than 1% per year.\n\n    Comorbidities\n16. Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability\n17. Acute myocardial infarction within the previous 30 day\n18. Any prior heart valve surgery or transcatheter mitral intervention\n19. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days\n20. Rheumatic heart disease or endocarditis within the previous 3 months\n21. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis\n22. Severe organic lesion with retracted chordae or congenital malformation and lack of valvular tissue\n23. Any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.\n24. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)\n25. Untreated clinically significant coronary artery disease requiring revascularization\n26. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation\n27. Aortic or pulmonic valve disease requiring surgery\n28. CRT\u002FICD implant within 30 days\n29. NYHA class IVb\n30. UNOS stadium 1 heart transplantation or previous orthotopic heart transplantation\n\n    Anatomical and Functional\n31. Left Ventricular Ejection Fraction (LVEF) \\\u003C30%\n32. LV end diastolic diameter \\> 70mm\n33. Significant abnormalities of the sub-valvular apparatus.\n34. Severe mitral annular or leaflets calcification\n35. Left atrial or LV thrombus or vegetation\n36. Severe right ventricular dysfunction\n37. Severe tricuspid or aortic valve disease",true,"ALL","18 Years",{"count":185,"type":186},60,"ESTIMATED","INTERVENTIONAL",[189],"NA","The Munich Trascatheter Mitral Valve System is intended for beating heart, mitral valve replacement in patients with a diseased, damaged, or malfunctioning mitral valve. Access is provided through the Femoral Vein and transseptal approach by means of a 27Fr catheter.\n\nThe bioprosthetic valve consists of a self-expanding, tri-leaflet, dry bovine-pericardial valve. The dry tissue allows the valve to be conveniently pre-loaded. The valve is available in three sizes and has been designed to reduce the complexity of implantation in comparison to other TMVR systems.",[192,193],"Mitral Regurgitation","Mitral Valve Disease",[195,196],"mitral regurgitation","heart failure","NOT_YET_RECRUITING","2023-07-07",{"date":200,"type":201},"2023-07-11","ACTUAL",{"date":203,"type":186},"2023-07-30",{"date":205,"type":186},"2029-12-30",{"name":5,"class":6},10]