[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519076":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":17,"centralContacts":38,"locations":48,"responsibleParty":116,"collaborators":17,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":17,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":17,"enrollmentInfo":127,"targetDuration":17,"studyType":130,"phases":131,"briefSummary":132,"conditions":133,"keywords":17,"overallStatus":51,"whyStopped":17,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Tioga Cardiovascular, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary Safety Endpoint","Number of subjects with all-cause mortality, cardiovascular-related hospitalizations, disabling stroke, and\u002For mitral valve reintervention or reoperation through 30 days post-procedure","From index procedure (Day 0) to 30 days post-procedure",{"measure":14,"description":15,"timeFrame":16},"Primary Performance Endpoint","Number of subjects achieving MVARC technical success - all of the following must be present at exit of catheterization lab:\n\n* Absence of procedural mortality\n* Successful access, delivery, and retrieval of the device delivery system\n* Successful deployment and correct positioning of the first intended device\n* Freedom from emergency surgery or reintervention related to the device or access procedure","At completion of index procedure (Day 0)",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","The Tioga TMVR Feasibility Study is a prospective, single-arm, multi-center study with a planned enrollment of up to 30 patients. The Tioga TMVR System is designed to percutaneously replace a patient's diseased native mitral valve with a bioprosthetic valve. The investigational device is intended for transseptal replacement of the mitral valve in patients with symptomatic MR (MR\\>=3+).",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"Patients with Symptomatic MR (MR>=3+)","EXPERIMENTAL","Subjects treated with the Tioga TMVR System",[31],"Device: Tioga TMVR System",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":17},"DEVICE","Tioga TMVR System","A bioprosthetic mitral valve, as part of the Tioga TMVR System, is implanted percutaneously in a patient with MR via transfemoral-transseptal access.",[27],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":17,"email":43},"Mariam Maghribi","CONTACT","510-705-2569","mariam@tiogamed.com",{"name":45,"role":41,"phone":46,"phoneExt":17,"email":47},"Tom Kelly","510-304-1117","tkelly@tiogamed.com",[49,65,79,88,102],{"facility":50,"status":51,"city":52,"state":17,"zip":17,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Incor - Instituto do Coração do Hospital das Clínicas da FMUSP","RECRUITING","São Paulo","Brazil","BR",{"type":56,"coordinates":57},"Point",[58,59],-46.63611,-23.5475,{"lat":59,"lon":58},[62],{"name":63,"role":41,"phone":17,"phoneExt":17,"email":64},"John Papazian","john.victorpapazian@hc.fm.usp.br",{"facility":66,"status":51,"city":67,"state":17,"zip":17,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Helsicore Hospital (Israeli Georgeian Medical Research Clinic Healthycore)","Tbilisi","Georgia","GE",{"type":56,"coordinates":71},[72,73],44.83412,41.69143,{"lat":73,"lon":72},[76],{"name":77,"role":41,"phone":17,"phoneExt":17,"email":78},"Dr Salome","salofifo@gmail.com",{"facility":80,"status":51,"city":67,"state":17,"zip":17,"country":68,"countryCode":69,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},"Tbilisi Heart and Vascular Clinic",{"type":56,"coordinates":82},[72,73],{"lat":73,"lon":72},[85],{"name":86,"role":41,"phone":17,"phoneExt":17,"email":87},"Dr Ketevan Gabunia","kgabunia@tbhc.ge",{"facility":89,"status":51,"city":90,"state":17,"zip":17,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Vilnius Univ. Hospital","Vilnius","Lithuania","LT",{"type":56,"coordinates":94},[95,96],25.2798,54.68916,{"lat":96,"lon":95},[99],{"name":100,"role":41,"phone":17,"phoneExt":17,"email":101},"Eglė Urbonaite","egle.urbonaite@santa.lt",{"facility":103,"status":51,"city":104,"state":17,"zip":17,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Sanatorio Italiano","Asunción","Paraguay","PY",{"type":56,"coordinates":108},[109,110],-57.647,-25.28646,{"lat":110,"lon":109},[113],{"name":114,"role":41,"phone":115,"phoneExt":17,"email":17},"Alvaro Cardenas","+595 983 788003",{"type":117,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100519076","feasibility-study-of-the-tioga-tmvr-system-100519076",false,"NCT06038838","Feasibility Study of the Tioga TMVR System","Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation","Inclusion Criteria:\n\n* Age 18 years or older\n* Symptomatic, moderate to severe (3+) or severe (4+) MR\n* NYHA Functional Classification ≥ II\n* Heart team concurs that the subject is non-ideal for surgical intervention or other available treatment options (e.g., TEER)\n* The subject or the subject's legal representative has been informed of the nature of the study, has agreed to return for post-procedure follow-up visits, and has provided informed consent\n\nExclusion Criteria:\n\n* LVEF \\\u003C 30%\n* LVEDD \\> 70 mm\n* Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, MAC) unsuitable for the Tioga TMVR System\n* Severe aortic valve stenosis or regurgitation\n* Severe right ventricular dysfunction or severe tricuspid valve disease\n* Evidence of intracardiac thrombus, vegetation, or mass\n* Prior mitral valve intervention\n* Prior prosthetic heart valve in any position\n* Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to enrollment\n* Any carotid surgery within 30 days prior to enrollment\n* Any open cardiac or vascular surgery (other than carotid surgery) within 90 days prior to enrolment\n* Myocardial infarction within 30 days prior to enrollment\n* Cardiac resynchronization therapy (CRT) device implanted within 30 days of enrollment\n* History of endocarditis within 6 months prior to enrollment or evidence of active systemic infection or sepsis.\n* Planned cardiovascular procedure within 30 days of enrolment\n* Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days of enrollment\n* Active peptic ulcer or active GI bleeding within 90 days of enrollment\n* Cardiogenic shock or hemodynamic instability requiring inotropic support or mechanical heart assistance\n* Pulmonary arterial hypertension with fixed PASP \\> 70mmHg or PVR \\> 5WU that cannot be reduced to less than 5WU with vasodilator therapy\n* Severe chronic obstructive pulmonary Disease (COPD) or airways disease requiring continuous home oxygen\n* Renal insufficiency (eGFR \\\u003C20 mL\u002Fmin) or ESRD on dialysis\n* Life expectancy \\\u003C 12 months\n* Subject is on the waiting list for a transplant or has had a prior heart transplant\n* Child class C cirrhosis\n* Blood dycrasias as defined by acute anemia with Hb \\\u003C 9, platelets \\\u003C 75K, WBC \\\u003C 0.5\n* Female subjects who is breast feeding or pregnant or planning to become pregnant within the study period.\n* Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution) or hypersensitivity to nickel or titanium\n* Inability to tolerate anticoagulation or antiplatelet therapies","ALL","18 Years",{"count":128,"type":129},30,"ESTIMATED","INTERVENTIONAL",[19],"The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\\>=3+)",[134],"Mitral Regurgitation","2025-11-07",{"date":137,"type":138},"2025-11-12","ACTUAL",{"date":140,"type":138},"2024-04-01",{"date":142,"type":129},"2028-07-01",{"name":5,"class":6},5]