[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tioga Cardiovascular, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"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":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"NA","The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR\\>=3+)",[25],"Mitral Regurgitation","RECRUITING","2025-11-07",{"date":29,"type":30},"2025-11-12","ACTUAL",{"date":32,"type":30},"2024-04-01",{"date":34,"type":19},"2028-07-01",{"name":36,"class":37},"Tioga Cardiovascular, Inc.","INDUSTRY",5,""]