[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624800":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":71,"collaborators":11,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":11,"eligibilityCriteria":78,"healthyVolunteers":75,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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",[27,41,51,61],{"facility":28,"status":29,"city":30,"state":11,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Beijing Anzhen Hospital, Capital Medical University","RECRUITING","Beijing","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.39723,39.9075,{"lat":37,"lon":36},[40],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"facility":42,"status":29,"city":30,"state":11,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":43,"geoPoint":45,"contacts":46},"Beijing Chaoyang Hospital, Capital Medical University",{"type":34,"coordinates":44},[36,37],{"lat":37,"lon":36},[47],{"name":48,"role":23,"phone":49,"phoneExt":11,"email":50},"Li Bo","13911365935","libo1976@mail.ccmu.edu.cn",{"facility":52,"status":29,"city":30,"state":11,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"Fu Wai Hospital, Chinese Academy of Medical Sciences",{"type":34,"coordinates":54},[36,37],{"lat":37,"lon":36},[57],{"name":58,"role":23,"phone":59,"phoneExt":11,"email":60},"Zhao Jie","13911036089","fwzhaojie@126.com",{"facility":62,"status":29,"city":30,"state":11,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences",{"type":34,"coordinates":64},[36,37],{"lat":37,"lon":36},[67],{"name":68,"role":23,"phone":69,"phoneExt":11,"email":70},"Xu Shangdong","18611021519","xushangdong@126.com",{"type":72,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100624800","safety-and-efficacy-of-the-renatus-transcatheter-aortic-valve-system-for-the-treatment-of-severe-aortic-stenosis-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":83,"type":84},800,"ESTIMATED","INTERVENTIONAL",[87],"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.",[90],"Severe Aortic Stenosis","2026-02-10",{"date":93,"type":94},"2026-02-17","ACTUAL",{"date":96,"type":84},"2026-02",{"date":98,"type":84},"2037-09",{"name":5,"class":6},4]