[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100377550":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":84,"collaborators":20,"id":86,"slug":20,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":20,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":20,"enrollmentInfo":94,"targetDuration":20,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Shanghai NewMed Medical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system",[13],"Device: Mi-thos® valve and transapical delivery system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Mi-thos® valve and transapical delivery system","Transcatheter mitral valve replacement system",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Wang chunsheng, Chief","Shanghai Zhongshan Hospital","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Wang chunyang, CRA","CONTACT","(86)-21-20788668","cywang@newmed.cn",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Xie xuyang, c","xyxie@newmed.cn",[36,54,69],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Fuwai hospital","RECRUITING","Beijing","Beijing Municipality","100044","China",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":52,"phoneExt":20,"email":53},"Zheng zhe, Chief","(+86)010-88396051","zhengzhe@fuwai.com",{"facility":55,"status":38,"city":56,"state":57,"zip":58,"country":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Zhongshan Hospital","Shanghai","Shanghai Municipality","200032",{"type":44,"coordinates":60},[61,62],121.45806,31.22222,{"lat":62,"lon":61},[65],{"name":23,"role":29,"phone":66,"phoneExt":67,"email":68},"(86)021-64041990","2512","cswang@medmail.com.cn",{"facility":70,"status":38,"city":71,"state":72,"zip":73,"country":42,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Xijing hospital","Xi’an","Shanxi","710032",{"type":44,"coordinates":75},[76,77],113.52486,35.99785,{"lat":77,"lon":76},[80],{"name":81,"role":29,"phone":82,"phoneExt":20,"email":83},"Yang jian, Chief","(+86)029-84774114","yangjian@fmmu.edu.cn",{"type":85,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100377550",false,"NCT04195984","Mi-thos® Transcatheter Mitral Valve Replacement Study","Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.","Inclusion Criteria:\n\n* Severe mitral valve regurgitation ≥ 3+;\n* High surgical risk fot open mitral valve surgery;\n* Age ≥ 65 years old;\n* Life expectancy \\> 12 months;\n* As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;\n* Patients sign an informed consent form.\n\nExclusion Criteria:\n\n* Previous cardiac mitral valve surgery;\n* Active infections requiring antibiotic therapy;\n* Clinically significant untreated Coronary Artery Disease (CAD);\n* Pulmonary hypertension （Pulmonary systolic pressure \\> 70 mmHg）;\n* Patients with severe right heart failure;\n* Left ventricular ejection fraction \\\u003C25%;\n* Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;\n* Dialysis patient;\n* Patients with severe coagulopathy;\n* Patients with contraindications to anticoagulant drugs;\n* Patients with stroke or transient ischemic within 30 days;\n* Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;\n* Patients who require surgery or interventional therapy for other valvular lesions;\n* Patients with severe macrovascular disease requiring surgical treatment;\n* Patients with more than 70% of carotid stenosis;\n* To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;\n* Patients with severe neurological disorders affecting cognitive ability;\n* Patients with severe thoracic deformities.","ALL","65 Years",{"count":95,"type":96},122,"ESTIMATED","INTERVENTIONAL",[99],"NA","To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.",[102],"Mitral Valve Regurgitation","2025-02-11",{"date":105,"type":106},"2025-02-13","ACTUAL",{"date":108,"type":106},"2021-03-25",{"date":110,"type":96},"2027-01",{"name":5,"class":6},3]