[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658134":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":49,"studyPopulation":53,"armGroups":54,"interventions":49,"overallOfficials":61,"centralContacts":66,"locations":76,"responsibleParty":252,"collaborators":254,"id":276,"slug":277,"hasResults":278,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":278,"sex":284,"minAge":285,"maxAge":49,"enrollmentInfo":286,"targetDuration":289,"studyType":290,"phases":49,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":79,"whyStopped":49,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":49},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Incidence of Major Adverse Events","Incidence of major adverse events related to the biodegradable PFO closure or transcatheter mitral valve edge-to-edge repair procedure during follow-up.","At 1, 6, and 12 months after the procedure",{"measure":14,"description":15,"timeFrame":12},"Anatomical success of PFO closure within 12 months after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography","The proportion of participants achieving successful anatomical closure of the patent foramen ovale (PFO) during the 12-month follow-up period after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography.",{"measure":17,"description":18,"timeFrame":12},"Incidence of the composite clinical outcome of heart failure hospitalization, all-cause mortality, or cardiovascular mortality within 12 months after transcatheter edge-to-edge mitral valve repair","The proportion of participants experiencing at least one of the following events during the 12-month follow-up period after TEER: hospitalization for heart failure, all-cause death, or cardiovascular death. Events will be assessed through clinical follow-up and review of medical records.",[20,23,27,30,33,36,40,43,46],{"measure":21,"description":22,"timeFrame":12},"Degree of device degradation","The degree of degradation of the biodegradable PFO closure device will be assessed by echocardiography during follow-up.",{"measure":24,"description":25,"timeFrame":26},"Incidence of residual shunt after PFO closure","The presence of residual shunt after implantation of the biodegradable PFO closure device will be assessed by echocardiography with contrast study, when applicable.","At 1, 6, and 12 months after the procedure.",{"measure":28,"description":29,"timeFrame":26},"Incidence of re-intervention after PFO closure","The percentage of participants requiring reapeat intervention or surgical treatment related to the PFO closure device during follow-up.",{"measure":31,"description":32,"timeFrame":26},"Incidence of recurrent stroke after PFO closure","The occurrence of recurrent ischemic or hemorrhagic stroke during the follow-up period will be assessed by clinical evaluation and review of medical records.",{"measure":34,"description":35,"timeFrame":26},"Incidence of device-related thrombosis after PFO closure","The occurrence of thrombosis related to the biodegradable PFO closure device during follow-up will be assessed by echocardiography and clinical assessment.",{"measure":37,"description":38,"timeFrame":39},"Proportion of participants who underwent TEER and achieved immediate procedural success","Immediate procedural success is defined as successful completion of the transcatheter mitral valve edge-to-edge repair procedure with post-procedural mitral regurgitation (MR) grade ≤2+, as assessed by echocardiography.","Within 24 hours after the procedure.",{"measure":41,"description":42,"timeFrame":26},"Incidence of subsequent open-heart surgery in the TEER group","The number of participants undergoing subsequent open-heart surgery related to TEER during follow-up.",{"measure":44,"description":45,"timeFrame":26},"Incidence of ischemic or hemorrhagic stroke in the TEER group","The occurrence of ischemic or hemorrhagic stroke during follow-up in the TEER group will be assessed by clinical evaluation and review of medical records.",{"measure":47,"description":48,"timeFrame":26},"Incidence of bleeding events in the TEER group","The occurrence of bleeding events during follow-up in the TEER group will be assessed by clinical evaluation and review of medical records.",null,{"allocation":49,"interventionModel":49,"interventionModelDescription":49,"primaryPurpose":49,"observationalModel":51,"timePerspective":52,"maskingInfo":49},"COHORT","PROSPECTIVE","1. Biodegradable PFO Closure Device Cohort: Patients with confirmed PFO-associated ischemic stroke who undergo implantation of a biodegradable PFO closure device.\n2. Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) Cohort: Patients with functional or degenerative mitral regurgitation who undergo transcatheter mitral valve edge-to-edge repair using a TEER system.",[55,58],{"label":56,"type":49,"description":57,"interventionNames":49},"Biodegradable Patent Foramen Ovale Closure Device","Participants with patent foramen ovale (PFO) who receive a biodegradable PFO closure device as part of routine clinical care will be included in this cohort. Clinical data will be collected to evaluate the safety and effectiveness of the device during follow-up.",{"label":59,"type":49,"description":60,"interventionNames":49},"Transcatheter Mitral Valve Edge-to-Edge Repair System Cohort","Participants with degenerative or functional mitral regurgitation who undergo transcatheter mitral valve edge-to-edge repair using a transcatheter mitral valve edge-to-edge repair system. Safety and effectiveness outcomes will be assessed during follow-up.",[62],{"name":63,"affiliation":64,"role":65},"Lijun Fu","Shanghai Children's Medical Center","PRINCIPAL_INVESTIGATOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":49,"email":71},"Xinyi Xu","CONTACT","+86 18930830756","3342@scmc.com.cn",{"name":73,"role":69,"phone":74,"phoneExt":49,"email":75},"Kai Wang","+86 15317921903","30192@scmc.com.cn",[77,97,114,130,146,162,178,194,210,225,237],{"facility":78,"status":79,"city":80,"state":81,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"The First Hospital of Lanzhou University","RECRUITING","Lanzhou","Gansu","China","CN",{"type":85,"coordinates":86},"Point",[87,88],103.83987,36.05701,{"lat":88,"lon":87},[91,95],{"name":92,"role":69,"phone":93,"phoneExt":49,"email":94},"Sixiong Hu","+86 17693433056","hsx1120587348@126.com",{"name":96,"role":65,"phone":49,"phoneExt":49,"email":49},"Jizhe Xu",{"facility":98,"status":99,"city":100,"state":101,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Guangdong Provincial People's Hospital","NOT_YET_RECRUITING","Guangzhou","Guangdong",{"type":85,"coordinates":103},[104,105],113.25,23.11667,{"lat":105,"lon":104},[108,112],{"name":109,"role":69,"phone":110,"phoneExt":49,"email":111},"Xiaotong Wen","+86 18123548072","1127337995@qq.com",{"name":113,"role":65,"phone":49,"phoneExt":49,"email":49},"Caojin Zhang",{"facility":115,"status":79,"city":116,"state":117,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Fuwai Central China Cardiovascular Hospital","Zhengzhou","Henan",{"type":85,"coordinates":119},[120,121],113.64861,34.75778,{"lat":121,"lon":120},[124,128],{"name":125,"role":69,"phone":126,"phoneExt":49,"email":127},"Menghao Li","+86 18790660032","edward564@163.com",{"name":129,"role":65,"phone":49,"phoneExt":49,"email":49},"Shubo Song",{"facility":131,"status":79,"city":132,"state":133,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Zhongnan Hospital of Wuhan University","Wuhan","Hubei",{"type":85,"coordinates":135},[136,137],114.26667,30.58333,{"lat":137,"lon":136},[140,144],{"name":141,"role":69,"phone":142,"phoneExt":49,"email":143},"Lei Wang","+86 18702797617","119559295@qq.com",{"name":145,"role":65,"phone":49,"phoneExt":49,"email":49},"Gangcheng Zhang",{"facility":147,"status":99,"city":148,"state":149,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"General Hospital of Northern Theater Command, Chinese People's Liberation Army","Shenyang","Liaoning",{"type":85,"coordinates":151},[152,153],123.43278,41.79222,{"lat":153,"lon":152},[156,160],{"name":157,"role":69,"phone":158,"phoneExt":49,"email":159},"Jiawang Xiao","+86 17790991821","xjw492918837@126.com",{"name":161,"role":65,"phone":49,"phoneExt":49,"email":49},"Qiguang Wang",{"facility":163,"status":99,"city":164,"state":165,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Shandong Provincial Hospital","Jinan","Shandong",{"type":85,"coordinates":167},[168,169],116.99722,36.66833,{"lat":169,"lon":168},[172,176],{"name":173,"role":69,"phone":174,"phoneExt":49,"email":175},"mingliang Dong","+86 13573157896","dongmingliang2008@126.com",{"name":177,"role":65,"phone":49,"phoneExt":49,"email":49},"Anbiao Wang",{"facility":179,"status":99,"city":180,"state":181,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Sichuan Provincial People's Hospital","Chengdu","Sichuan",{"type":85,"coordinates":183},[184,185],104.06667,30.66667,{"lat":185,"lon":184},[188,192],{"name":189,"role":69,"phone":190,"phoneExt":49,"email":191},"Xuechun Sun","+86 18981838108","sunxchun@163.com",{"name":193,"role":65,"phone":49,"phoneExt":49,"email":49},"Yunshan Cao",{"facility":195,"status":99,"city":196,"state":197,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences\u002FAffiliated Cardiovascular Hospital of Kunming Medical University","Kunming","Yunnan",{"type":85,"coordinates":199},[200,201],102.71833,25.03889,{"lat":201,"lon":200},[204,208],{"name":205,"role":69,"phone":206,"phoneExt":49,"email":207},"Kairui Yang","+86 13987313055","416719379@qq.com",{"name":209,"role":65,"phone":49,"phoneExt":49,"email":49},"Cheng Wang",{"facility":211,"status":99,"city":212,"state":49,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Beijing Anzhen Hospital, Capital Medical University","Beijing",{"type":85,"coordinates":214},[215,216],116.39723,39.9075,{"lat":216,"lon":215},[219,223],{"name":220,"role":69,"phone":221,"phoneExt":49,"email":222},"Yizhen Yang","+86 13261985610","yangyizhen2005@126.com",{"name":224,"role":65,"phone":49,"phoneExt":49,"email":49},"Wenhui Wu",{"facility":226,"status":99,"city":212,"state":49,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":227,"geoPoint":229,"contacts":230},"FUWAI Hospital, CAMS&PUMC",{"type":85,"coordinates":228},[215,216],{"lat":216,"lon":215},[231,235],{"name":232,"role":69,"phone":233,"phoneExt":49,"email":234},"Jing Dong","+86 15810174302","Djing0324@163.com",{"name":236,"role":65,"phone":49,"phoneExt":49,"email":49},"Guangzhi Zhao",{"facility":238,"status":99,"city":239,"state":49,"zip":49,"country":82,"countryCode":83,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"East Hospital, Tongji University","Shanghai",{"type":85,"coordinates":241},[242,243],121.45806,31.22222,{"lat":243,"lon":242},[246,250],{"name":247,"role":69,"phone":248,"phoneExt":49,"email":249},"Ying Hao","+86 18049898248","supergreathy@163.com",{"name":251,"role":65,"phone":49,"phoneExt":49,"email":49},"Linxiang Lu",{"type":65,"investigatorFullName":63,"investigatorTitle":253,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Chief Physician",[255,257,258,260,262,264,265,267,269,272,274],{"name":256,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital",{"name":98,"class":6},{"name":259,"class":6},"LanZhou University",{"name":163,"class":261},"OTHER_GOV",{"name":263,"class":6},"Beijing Anzhen Hospital",{"name":179,"class":6},{"name":266,"class":6},"Zhongnan Hospital",{"name":268,"class":6},"Shanghai East Hospital of Tongji University",{"name":270,"class":271},"ScienTech Medical","UNKNOWN",{"name":273,"class":271},"Valgen Medtech",{"name":275,"class":6},"The General Hospital of Northern Theater Command","100658134","active-surveillance-and-safetyefficacy-evaluation-of-innovative-devices-for-structural-heart-disease-intervention-100658134",false,"NCT07848152","Active Surveillance and Safety\u002FEfficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention","Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease","ASSEE-SHD","Inclusion Criteria:\n\n1. Patients undergoing implantation of a biodegradable PFO closure device.\n2. Patients undergoing transcatheter mitral valve edge-to-edge repair.\n\nExclusion Criteria:\n\nThe participant expresses a desire to withdraw from the study.","ALL","18 Years",{"count":287,"type":288},2200,"ESTIMATED","12 Months","OBSERVATIONAL","This study aims to establish an active surveillance system to evaluate the safety and effectiveness of innovative medical devices used in the interventional treatment of structural heart disease. The devices of interest include a biodegradable patent foramen ovale (PFO) closure device and a transcatheter mitral valve edge-to-edge repair system. Clinical information from patients receiving these devices during routine clinical care will be collected and analyzed. The findings will help evaluate the safety and effectiveness of these devices and support the development of appropriate clinical evaluation indicators and long-term monitoring strategies.",[293,56],"Transcatheter Mitral Valve Edge-to-Edge Repair System",[295,296],"Patent Foramen Ovale Closure Device","Transcatheter Mitral Valve Edge-to-Edge Repair","2026-09-26",{"date":299,"type":300},"2026-09-29","ACTUAL",{"date":302,"type":300},"2025-12-30",{"date":304,"type":288},"2029-01-31",{"name":5,"class":6},11]