[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ReValve Solutions Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100639768","early-phase-1-replacement-of-the-native-mitral-valve-using-the-revalve-system-100639768",false,"NCT07601269","Replacement of the Native Mitral Valve Using the ReValve System","A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System","Key Inclusion Criteria:\n\n* Symptomatic functional and\u002For degenerative MR (≥2+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study.\n* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.\n* Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac CT.\n* Age greater than 18 years.\n* Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent.\n\nKey Exclusion Criteria:\n\n* Untreated clinically significant coronary artery disease requiring revascularization.\n* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n* Status 1 heart transplant or prior orthotopic heart transplantation.\n* Cerebrovascular accident within 30 days prior to subject's consent.\n* Pregnant or planning pregnancy within next 12 months.\n* Currently participating in an investigational drug or another device study.\n* Evidence of LV or LA thrombus, vegetation or mass\n* Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This study is to collect preliminary chronic information on performance and safety of the ReValve System.",[26],"Mitral Valve Replacement","RECRUITING","2026-05-16",{"date":30,"type":31},"2026-05-22","ACTUAL",{"date":33,"type":31},"2026-04-26",{"date":35,"type":20},"2028-04",{"name":37,"class":38},"ReValve Solutions Inc.","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":21,"phases":46,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":59},"100627613","phase-1-a-clinical-study-evaluating-the-replacement-of-the-native-mitral-valve-using-the-revalve-system-100627613","NCT07450911","Key Inclusion Criteria:\n\n* Symptomatic MR (≥3+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study.\n* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.\n* Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI)).\n* Age greater than 18 years\n* Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent.\n\nKey Exclusion Criteria:\n\n* Untreated clinically significant coronary artery disease requiring revascularization.\n* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.\n* Status 1 heart transplant or prior orthotopic heart transplantation\n* Cerebrovascular accident within 30 days prior to subject's consent\n* Pregnant or planning pregnancy within next 12 months.\n* Currently participating in an investigational drug or another device study.\n* Evidence of LV or left atrium (LA) thrombus, vegetation or mass\n* Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.",{"count":45,"type":20},20,[47],"PHASE1","An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.",[50],"Mitral Regurgitation","2026-03-03",{"date":53,"type":31},"2026-03-05",{"date":55,"type":31},"2026-01-27",{"date":57,"type":20},"2028-01-01",{"name":37,"class":38},3,""]