[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611639":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":53,"collaborators":19,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":19,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":19,"enrollmentInfo":64,"targetDuration":19,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":19,"overallStatus":73,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Hangzhou Valgen Medtech Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"DragonFly M2 Transcatheter Mitral Valve Repair System","EXPERIMENTAL","Transcatheter mitral valve repair with the DragonFly M2 System in patients with degenerative mitral regurgitation",[13],"Device: DragonFly M2 Transcatheter Mitral Valve Repair System",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","Edge-to-edge repair with DragonFly M2 System",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Xiangbin Pan","Chinese Academy of Medical Sciences, Fuwai Hospital","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Bo Liu","CONTACT","+86 13001980902","bo.liu@valgenmed.com",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Xiaoxu Yang","+8618910330079","xiaoxu.yang@valgenmed.com",[36],{"facility":37,"status":19,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Fuwai Hospital Chinese Academy of Medical Sciences","Shenzhen","Guangdong","518000","China","CN",{"type":44,"coordinates":45},"Point",[46,47],114.0683,22.54554,{"lat":47,"lon":46},[50],{"name":51,"role":28,"phone":52,"phoneExt":19,"email":19},"Xiangbin Pan, MD, PH.D","+8618010155168",{"type":54,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100611639","dragonfly-m2-pivotal-study-100611639",false,"NCT07243197","DragonFly M2 Pivotal Study","Safety and Performance Evaluation Study of DragonFly M2 System for Mitral Regurgitation","Inclusion Criteria:\n\n1.≥ 18 years old. 2.Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography.\n\n* Transseptal catheterization is determined to be feasible by the Investigator.\n* Patients have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF.\n\nExclusion Criteria:\n\n1)Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2) The presence of other severe heart valve disease requiring surgical intervention.\n\n3\\) Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.\n\n* Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.\n* In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.","ALL","18 Years",{"count":65,"type":66},53,"ESTIMATED","INTERVENTIONAL",[69],"NA","To confirm the effectiveness and safety of the DragonFly M2 Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects.The safety and effectiveness of the first-generation device(Dragonfly Transcatheter Mitral Valve Repair System)have been previously demonstrated. This study aims to further confirm the safety and effectiveness of the new device following structural optimization based on the first-generation design.",[72],"Mitral Valve (MV) Regurgitation","NOT_YET_RECRUITING","2025-11-17",{"date":76,"type":77},"2025-11-21","ACTUAL",{"date":79,"type":66},"2026-01-15",{"date":81,"type":66},"2031-06-30",{"name":5,"class":6},1]