[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624800":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":70,"collaborators":11,"id":72,"slug":11,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Beijing Balance Medical Technology Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RENATUS® TAVR treatment","EXPERIMENTAL",null,[13],"Device: RENATUS® TAVR",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","RENATUS® TAVR","RENATUS® Transcatheter Aortic Valve System，an approved marketed TAVR",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Lai Yongqiang","CONTACT","010-64456376","yongqianglai@outlook.com",[27,40,50,60],{"facility":28,"status":29,"city":30,"state":11,"zip":11,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Beijing Anzhen Hospital, Capital Medical University","RECRUITING","Beijing","China",{"type":33,"coordinates":34},"Point",[35,36],116.39723,39.9075,{"lat":36,"lon":35},[39],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"facility":41,"status":29,"city":30,"state":11,"zip":11,"country":31,"cosmosGeoPoint":42,"geoPoint":44,"contacts":45},"Beijing Chaoyang Hospital, Capital Medical University",{"type":33,"coordinates":43},[35,36],{"lat":36,"lon":35},[46],{"name":47,"role":23,"phone":48,"phoneExt":11,"email":49},"Li Bo","13911365935","libo1976@mail.ccmu.edu.cn",{"facility":51,"status":29,"city":30,"state":11,"zip":11,"country":31,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Fu Wai Hospital, Chinese Academy of Medical Sciences",{"type":33,"coordinates":53},[35,36],{"lat":36,"lon":35},[56],{"name":57,"role":23,"phone":58,"phoneExt":11,"email":59},"Zhao Jie","13911036089","fwzhaojie@126.com",{"facility":61,"status":29,"city":30,"state":11,"zip":11,"country":31,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences",{"type":33,"coordinates":63},[35,36],{"lat":36,"lon":35},[66],{"name":67,"role":23,"phone":68,"phoneExt":11,"email":69},"Xu Shangdong","18611021519","xushangdong@126.com",{"type":71,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100624800",false,"NCT07414342","Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis","Inclusion Criteria:\n\n1. Patients deemed eligible for TAVR by the treating physician, including those at high, intermediate, or low surgical risk, with a calculated Society of Thoracic Surgeons (STS) risk score;\n2. Symptomatic patients with severe aortic stenosis, defined by echocardiography as having at least one of the following:\n\n   * Mean transvalvular pressure gradient ≥40 mmHg (1 mmHg = 0.133 kPa),\n   * Peak aortic jet velocity ≥4.0 m\u002Fs,\n   * Aortic valve area \\\u003C1.0 cm², or Indexed effective orifice area \\\u003C0.6 cm²\u002Fm²;\n3. Patients who understand the purpose of the trial, voluntarily agree to participate, provide written informed consent, and are willing to undergo required examinations and clinical follow-up.\n\nExclusion Criteria:\n\n1. Patients with a life expectancy of ≤1 year following prosthetic valve implantation;\n2. Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month;\n3. Patients with minimal or no calcification of the aortic annulus;\n4. Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation;\n5. Patients with multivalvular disease (severe stenosis and\u002For regurgitation);\n6. Patients with hematologic cachexia, including leukopenia (WBC \\\u003C3×10⁹\u002FL), acute anemia (Hb \\\u003C90 g\u002FL), thrombocytopenia (PLT \\\u003C50×10⁹\u002FL), bleeding diathesis, or coagulopathy;\n7. Patients with untreated coronary artery disease requiring revascularization;\n8. Patients with obstructive hypertrophic cardiomyopathy;\n9. Patients with severe left ventricular dysfunction (LVEF \\\u003C20%);\n10. Patients with severe right ventricular dysfunction;\n11. Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography;\n12. Patients unable to tolerate anticoagulant or antiplatelet therapy;\n13. Patients who have experienced a cerebrovascular accident (CVA)-including ischemic or hemorrhagic stroke-within the past 3 months;\n14. Patients with decompensated renal insufficiency;\n15. Patients with active infective endocarditis or other active infections;\n16. Patients with untreated conduction system disease requiring pacemaker implantation;\n17. Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint;\n18. Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention.","ALL","60 Years","100 Years",{"count":81,"type":82},800,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study is a prospective, non-randomized, observational, post-market follow-up trial designed to evaluate the safety and efficacy of the RENATUS® Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.",[88],"Severe Aortic Stenosis","2026-02-10",{"date":91,"type":92},"2026-02-17","ACTUAL",{"date":94,"type":82},"2026-02",{"date":96,"type":82},"2037-09",{"name":5,"class":6},4]