[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552202":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":62,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":24,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":24,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Aarhus University Hospital Skejby","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Medtronic Evolut FX","ACTIVE_COMPARATOR","TAVI procedure performed with Medtronic Evolut FX",[13],"Device: Medtronic Evolut FX",{"label":15,"type":10,"description":16,"interventionNames":17},"Edwards Sapien Ultra 3 Resilia","TAVI procedure performed with Edwards Sapien Ultra 3 Resilia",[18],"Device: Edwards Sapien 3 Ultra Resilia",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","TAVI performed with Medtronic Evolut FX",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Edwards Sapien 3 Ultra Resilia","TAVI performed with Edwards Sapien 3 Ultra Resilia",[15],[30],{"name":31,"affiliation":32,"role":33},"christian J Terkelsen, Professor","Department of cardiology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Christian J Terkelsen, Professor","CONTACT","+4540135388","CHRITERK@RM.DK",{"name":41,"role":37,"phone":42,"phoneExt":24,"email":43},"Helle Bargsteen","+4578452112","hellbarg@rm.dk",[45],{"facility":46,"status":47,"city":48,"state":24,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Department of cardiology, Aarhus University Hospital","RECRUITING","Aarhus","8200","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],10.21076,56.15674,{"lat":56,"lon":55},[59],{"name":60,"role":37,"phone":61,"phoneExt":24,"email":24},"Christian J Terkelsen, Prof","004540135388",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Christian Juhl Terkelsen","Professor, MD, DmSc, PhD",[67],{"name":68,"class":69},"Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark","UNKNOWN","100552202","comparison-of-evolut-fx-versus-sapien-3-ultra-resilia-100552202",false,"NCT06470022","Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.","Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial","COMPARE-TAVI","Inclusion Criteria:\n\n1. Patient more than 18 years of age.\n2. Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia according to a TAVI heart team conference.\n3. The center experience for each of the valves considered should be more than 15 cases a year, and the treating physician should have implanted at least 15 of each valve used in the trial.\n4. The center volume should be more than 75 cases a year.\n5. The patient has given signed informed consent.\n6. TAVI performed via the femoral artery.\n\nExclusion Criteria:\n\nNone",true,"ALL","18 Years",{"count":82,"type":83},1346,"ESTIMATED","INTERVENTIONAL",[86],"NA","To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.",[89],"Aortic Stenosis","2026-04-22",{"date":92,"type":93},"2026-04-28","ACTUAL",{"date":95,"type":93},"2024-08-09",{"date":97,"type":83},"2036-12-01",{"name":64,"class":6},1]