[{"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:":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"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":5},"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":18,"type":19},25,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","This study is to collect preliminary chronic information on performance and safety of the ReValve System.",[25],"Mitral Valve Replacement","RECRUITING","2026-05-16",{"date":29,"type":30},"2026-05-22","ACTUAL",{"date":32,"type":30},"2026-04-26",{"date":34,"type":19},"2028-04",{"name":36,"class":37},"ReValve Solutions Inc.","INDUSTRY",{"id":39,"slug":4,"hasResults":10,"nctId":40,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":41,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":42,"targetDuration":4,"studyType":20,"phases":44,"briefSummary":46,"conditions":47,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":57},"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":43,"type":19},20,[45],"PHASE1","An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.",[48],"Mitral Regurgitation","2026-03-03",{"date":51,"type":30},"2026-03-05",{"date":53,"type":30},"2026-01-27",{"date":55,"type":19},"2028-01-01",{"name":36,"class":37},3,""]