[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515420":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":23,"slug":24,"hasResults":25,"nctId":26,"briefTitle":27,"officialTitle":28,"acronym":20,"eligibilityCriteria":29,"healthyVolunteers":25,"sex":30,"minAge":31,"maxAge":20,"enrollmentInfo":32,"targetDuration":20,"studyType":35,"phases":36,"briefSummary":38,"conditions":39,"keywords":20,"overallStatus":41,"whyStopped":20,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":20},{"fullName":5,"class":6},"Venus MedTech (HangZhou) Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"procedure","EXPERIMENTAL","implant valve by TAVR",[13],"Device: Venus-Vitae Transcatheter Heart Valve System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Venus-Vitae Transcatheter Heart Valve System","The Venus-Vitae THV is comprised of balloon-expandable and radiopaque cobalt-chromium alloy frame, porcine pericardium tri-leaflet, porcine pericardium inner skirt, polyurethane outer skirt, PTFE assembly sutures, and three radiopaque gold markers (Figure 1). The valve utilizes Venus Endura technology and stored in a non-aqueous condition.",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100515420","venus-vitae-pivotal-study-smart-align-study-100515420",false,"NCT05991271","Venus-Vitae Pivotal Study Smart-Align Study","Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients with the symptoms of severe aortic stenosis\n3. Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2\u002Fm3) or Vmax ≥ 4.0 m\u002Fs or MPG ≥ 40 mmHg determined by echocardiography\n4. Patients deemed for cardiac intervention by a heart team\n5. Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.\n6. Patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements\n\nExclusion Criteria:\n\nA subject meeting any of the following criteria shall be excluded:\n\nCo-morbidities\n\n1. Previous mechanical or biological aortic valve replacement\n2. Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention\n3. Acute myocardial infact within 30 days prior to index procedure\n4. Untreated clinical significant coronary artery disease requiring revascularization\n5. Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent\u002Fscaffold implant within 6 months)\n6. Sever symptomatic carotid artery stenosis\n7. Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability\n8. Chronic kidney disease (eGFR\\\u003C30 mL\u002Fmin\u002F1.73m2)\n9. Haemotologic disorders: Leukopenia (WBC \\\u003C 3000 cell\u002FmL), anemia (Hgb \\\u003C 9 g\u002FdL), thrombocytopenia (Plt\\\u003C 50,000 cell\u002FmL), or any known blood clotting disorder, deemed clinically significant after consultation with Haematooncology specialists\n10. Severe right heart dysfunction Anatomical\n11. LVEF \\\u003C 20%\n12. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation\n13. Inappropriate anatomy for femoral introduction and delivery of study device\n14. Native aortic valve geometry and size unfavorable for study device anchoring General\n15. Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance\n16. Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement\n17. Life expectancy ≤ 1 year due to noncardiac reasons\n18. Active infection requiring antibiotic therapy including infective endocarditis\n19. Planned relevant concomitant procedure within 30 days post index procedure\n20. Pregnant, breastfeeding or intend to become pregnant within 1 year","ALL","18 Years",{"count":33,"type":34},150,"ESTIMATED","INTERVENTIONAL",[37],"NA","The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.",[40],"Aortic Valve Stenosis","NOT_YET_RECRUITING","2023-08-14",{"date":44,"type":45},"2023-08-18","ACTUAL",{"date":47,"type":34},"2023-10-31",{"date":49,"type":34},"2029-06-30",{"name":5,"class":6}]