[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597538":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":34,"responsibleParty":196,"collaborators":198,"id":206,"slug":207,"hasResults":208,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":208,"sex":214,"minAge":215,"maxAge":10,"enrollmentInfo":216,"targetDuration":10,"studyType":219,"phases":10,"briefSummary":220,"conditions":221,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Edwards Lifesciences","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MITRIS RESILIA Mitral Valve",null,"Subjects who received the MITRIS RESILIA Mitral Valve, Model 11400M",[13],"Device: MITRIS RESILIA Mitral Valve",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DEVICE","Surgical replacement of native or prosthetic mitral valve.",[9],[20],{"name":21,"affiliation":22,"role":23},"Wei Feng, Professor","Chinese Academy of Medical Sciences, Fuwai Hospital","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Honglei Sun","CONTACT","+8610 5641 0883","Honglei_Sun@edwards.com",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"WeiDavid Zhang","+86 010 56410915","WeiDavid_Zhang@edwards.com",[35,52,61,74,87,100,109,122,135,144,157,170,183],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Beijing Anzhen Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100029","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":51,"role":23,"phone":10,"phoneExt":10,"email":10},"Yongqiang Lai, Professor",{"facility":53,"status":37,"city":38,"state":39,"zip":54,"country":41,"countryCode":42,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"Fuwai Hospital, CAMS & PUMC","100037",{"type":44,"coordinates":56},[46,47],{"lat":47,"lon":46},[59],{"name":60,"role":23,"phone":10,"phoneExt":10,"email":10},"Wei Fang, Professor",{"facility":62,"status":37,"city":63,"state":64,"zip":65,"country":41,"countryCode":42,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Xiamen Cardiovascular Hospital Xiamen University","Xiamen","Fujian","361008",{"type":44,"coordinates":67},[68,69],118.08187,24.47979,{"lat":69,"lon":68},[72],{"name":73,"role":23,"phone":10,"phoneExt":10,"email":10},"Zhi Lin, Professor",{"facility":75,"status":37,"city":76,"state":77,"zip":78,"country":41,"countryCode":42,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Guangdong Provincial People's Hospital","Guangzhou","Guangdong","510080",{"type":44,"coordinates":80},[81,82],113.25,23.11667,{"lat":82,"lon":81},[85],{"name":86,"role":23,"phone":10,"phoneExt":10,"email":10},"Huiming Guo, Professor",{"facility":88,"status":37,"city":89,"state":90,"zip":91,"country":41,"countryCode":42,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan","450052",{"type":44,"coordinates":93},[94,95],113.64861,34.75778,{"lat":95,"lon":94},[98],{"name":99,"role":23,"phone":10,"phoneExt":10,"email":10},"Xin Zhang, Professor",{"facility":101,"status":37,"city":89,"state":90,"zip":102,"country":41,"countryCode":42,"cosmosGeoPoint":103,"geoPoint":105,"contacts":106},"Fuwai Central China Cardiovascular Hospital","451460",{"type":44,"coordinates":104},[94,95],{"lat":95,"lon":94},[107],{"name":108,"role":23,"phone":10,"phoneExt":10,"email":10},"Zhaoyun Cheng, Professor",{"facility":110,"status":37,"city":111,"state":112,"zip":113,"country":41,"countryCode":42,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Wuhan Asia Heart Hospital","Wuhan","Hubei","430022",{"type":44,"coordinates":115},[116,117],114.26667,30.58333,{"lat":117,"lon":116},[120],{"name":121,"role":23,"phone":10,"phoneExt":10,"email":10},"Zhengdong Hua, Professor",{"facility":123,"status":37,"city":124,"state":125,"zip":126,"country":41,"countryCode":42,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Nanjing Drum Tower Hospital","Nanjing","Jiangsu","210000",{"type":44,"coordinates":128},[129,130],118.77778,32.06167,{"lat":130,"lon":129},[133],{"name":134,"role":23,"phone":10,"phoneExt":10,"email":10},"Qing Zhou, Professor",{"facility":136,"status":37,"city":124,"state":125,"zip":137,"country":41,"countryCode":42,"cosmosGeoPoint":138,"geoPoint":140,"contacts":141},"Nanjing First Hospital","210012",{"type":44,"coordinates":139},[129,130],{"lat":130,"lon":129},[142],{"name":143,"role":23,"phone":10,"phoneExt":10,"email":10},"Xin Chen, Professor",{"facility":145,"status":37,"city":146,"state":147,"zip":148,"country":41,"countryCode":42,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"The First Affiliated Hospital of XI'an Jiaotong University","Xi'an","Shaanxi","710061",{"type":44,"coordinates":150},[151,152],108.92861,34.25833,{"lat":152,"lon":151},[155],{"name":156,"role":23,"phone":10,"phoneExt":10,"email":10},"Yang Yan, Professor",{"facility":158,"status":37,"city":159,"state":160,"zip":161,"country":41,"countryCode":42,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Qilu Hospital of Shandong University","Jinan","Shandong","250012",{"type":44,"coordinates":163},[164,165],116.99722,36.66833,{"lat":165,"lon":164},[168],{"name":169,"role":23,"phone":10,"phoneExt":10,"email":10},"Xin Zhao, Professor",{"facility":171,"status":37,"city":172,"state":173,"zip":174,"country":41,"countryCode":42,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Sichuan Provincial People's Hospital","Chengdu","Sichuan","610072",{"type":44,"coordinates":176},[177,178],104.06667,30.66667,{"lat":178,"lon":177},[181],{"name":182,"role":23,"phone":10,"phoneExt":10,"email":10},"Keli Huang, Professor",{"facility":184,"status":37,"city":185,"state":186,"zip":187,"country":41,"countryCode":42,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Ningbo Medical Center Lihuili Hospital","Ningbo","Zhejiang","315046",{"type":44,"coordinates":189},[190,191],121.54945,29.87819,{"lat":191,"lon":190},[194],{"name":195,"role":23,"phone":10,"phoneExt":10,"email":10},"Guofeng Shao, Professor",{"type":197,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[199,202,204],{"name":200,"class":201},"Edwards (Shanghai) Medical Products Co. Ltd.","UNKNOWN",{"name":203,"class":201},"Kun Tuo Medical Research and Development (Beijing) Co. Ltd.",{"name":22,"class":205},"OTHER","100597538","mitris-china-post-market-clinical-follow-up-pmcf-study-100597538",false,"NCT07059793","MITRIS China Post Market Clinical Follow-up (PMCF) Study","Post-Market Clinical Follow-up Study of Edwards Lifesciences MITRIS RESILIA Mitral Valve in Chinese Population","MITRIS China","Inclusion Criteria:\n\n1. 18 years or older at the time of informed consent\n2. Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery\n3. Provide signed written informed consent prior to the study participation\n4. Willingness to follow protocol requirements\n\nExclusion Criteria:\n\n1. Active endocarditis 3 months prior to the procedure\n2. Stage 4 renal disease or requiring dialysis (eGFR \\\u003C 30 is excluded)\n3. Less than 2-year life expectancy due to non-cardiovascular life-threatening disease\n4. High predicted risk of mortality prior to procedure - STS Predicted Risk of Mortality (PROM) \\> 8 or Surgeon estimated risk of mortality of \\> 8 (STS PROM risk calculation score must be used for patients undergoing Isolated Mitral Valve Replacement (MVR) or MVR+ Coronary Artery Bypass Grafting (CABG). Surgeon estimated risk of mortality may only be used for patients who do not qualify for evaluation against those surgical models.)\n5. Participating in a drug or device study that has not reached its primary endpoint. Note: Participation in national registries is not an exclusion.","ALL","18 Years",{"count":217,"type":218},250,"ESTIMATED","OBSERVATIONAL","Collect clinical outcomes on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.",[222],"Mitral Valve Replacement","2025-12-23",{"date":225,"type":226},"2025-12-30","ACTUAL",{"date":228,"type":226},"2025-07-08",{"date":230,"type":218},"2038-12",{"name":5,"class":6},13]