[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Balance Medical Technology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":19,"type":20},800,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Severe Aortic Stenosis","RECRUITING","2026-02-10",{"date":30,"type":31},"2026-02-17","ACTUAL",{"date":33,"type":20},"2026-02",{"date":35,"type":20},"2037-09",{"name":37,"class":38},"Beijing Balance Medical Technology Co., Ltd","INDUSTRY",4,""]