[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100377550":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":85,"collaborators":20,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":20,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":20,"enrollmentInfo":96,"targetDuration":20,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":20,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"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",[36,55,70],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Fuwai hospital","RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":53,"phoneExt":20,"email":54},"Zheng zhe, Chief","(+86)010-88396051","zhengzhe@fuwai.com",{"facility":56,"status":38,"city":57,"state":58,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Zhongshan Hospital","Shanghai","Shanghai Municipality","200032",{"type":45,"coordinates":61},[62,63],121.45806,31.22222,{"lat":63,"lon":62},[66],{"name":23,"role":29,"phone":67,"phoneExt":68,"email":69},"(86)021-64041990","2512","cswang@medmail.com.cn",{"facility":71,"status":38,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Xijing hospital","Xi’an","Shanxi","710032",{"type":45,"coordinates":76},[77,78],113.52486,35.99785,{"lat":78,"lon":77},[81],{"name":82,"role":29,"phone":83,"phoneExt":20,"email":84},"Yang jian, Chief","(+86)029-84774114","yangjian@fmmu.edu.cn",{"type":86,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100377550","mi-thos-transcatheter-mitral-valve-replacement-study-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":97,"type":98},122,"ESTIMATED","INTERVENTIONAL",[101],"NA","To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.",[104],"Mitral Valve Regurgitation","2025-02-11",{"date":107,"type":108},"2025-02-13","ACTUAL",{"date":110,"type":108},"2021-03-25",{"date":112,"type":98},"2027-01",{"name":5,"class":6},3]