[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611636":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":64,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":25,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Hangzhou Valgen Medtech Co., Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Randomized - Device Group","EXPERIMENTAL","This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.",[13,14],"Device: DragonFly System","Drug: Drug",{"label":16,"type":17,"description":18,"interventionNames":19},"Randomized - Control Group","ACTIVE_COMPARATOR","This group will continue to be managed on medical therapy, per physician discretion",[13,14],[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE","DragonFly System",[16,9],null,{"type":27,"name":28,"description":18,"armGroupLabels":29,"otherNames":25},"DRUG","Drug",[16,9],[31],{"name":32,"affiliation":33,"role":34},"Jianan Wang","Second Affiliated Hospital, School of Medicine, Zhejiang University","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Bo Liu","CONTACT","+86 13001980902","bo.liu@valgenmed.com",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Xiaoxu Yang","+86 18910330079","xiaoxu.yang@valgenmed.com",[46],{"facility":47,"status":25,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"The Second Affiliated Hospital Zhejiang University School of Medicine","Hangzhou","Zhejiang","310000","China","CN",{"type":54,"coordinates":55},"Point",[56,57],120.16142,30.29365,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":25,"email":63},"Jianan Wang, MD, PH.D","+8613805786328","wja@zju.edu.cn",{"type":65,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100611636","randomized-controlled-study-of-dragonfly-system-for-functional-mitral-regurgitation-100611636",false,"NCT07243158","Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation","A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of the DragonFly Transcatheter Mitral Valve Clip System in the Treatment of Moderate-to-Severe or Severe Functional Mitral Regurgitation (FMR)","Inclusion Criteria:\n\n1\\) Age ≥ 18 yrs. 2) Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy\n\n* Transseptal catheterization and femoral vein access is determined to be feasible.\n* The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.\n\nExclusion Criteria:\n\n1\\) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2）Echocardiography revealed severe restriction of leaflet motion due to tethering.\n\n3\\) The presence of other severe heart valve disease requiring surgical 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":76,"type":77},148,"ESTIMATED","INTERVENTIONAL",[80],"NA","To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.",[83],"Mitral Regurgitation Functional","NOT_YET_RECRUITING","2025-11-17",{"date":87,"type":88},"2025-11-21","ACTUAL",{"date":90,"type":77},"2025-12-30",{"date":92,"type":77},"2030-06-30",{"name":5,"class":6},1]