[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629617":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":21,"locations":30,"responsibleParty":48,"collaborators":11,"id":51,"slug":11,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":11},"No post-dilatation after THV deployment","NO_INTERVENTION",null,{"label":13,"type":14,"description":11,"interventionNames":15},"Nominal post-dilatation using the original delivery balloon","EXPERIMENTAL",[16],"Other: Post-dilatation",[18],{"type":6,"name":19,"description":13,"armGroupLabels":20,"otherNames":11},"Post-dilatation",[13],[22,27],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},"Christian Nitsche, MD, PhD","CONTACT","+43-1-40400-48590","christian.nitsche@meduniwien.ac.at",{"name":28,"role":24,"phone":25,"phoneExt":11,"email":29},"Philipp E Bartko, MD, PhD","philippemanuel.bartko@meduniwien.ac.at",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Vienna","State of Vienna","1090","Austria",{"type":38,"coordinates":39},"Point",[40,41],16.37208,48.20849,{"lat":41,"lon":40},[44,45,46],{"name":23,"role":24,"phone":25,"phoneExt":11,"email":26},{"name":28,"role":24,"phone":25,"phoneExt":11,"email":29},{"name":23,"role":47,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Christian Nitsche","MD, PhD","100629617",false,"NCT07477002","Post-Dilatation in Balloon-Expandable TAVI Prostheses","Effects of Post-Dilatation on THV Expansion, Hemodynamics, Durability, and Outcomes in Balloon-Expandable TAVI Prostheses","DUOTAP","Inclusion Criteria:\n\n* Severe AS\n* AS treatment by transfemoral TAVI as determined by an interdisciplinary heart team board\n* Anatomical feasibility to receive a balloon-expandable THV\n* Age 65 years or older\n* Informed consent\n\nExclusion Criteria:\n\n* Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., non compliant, perforated)\n* Bicuspid aortic valve anatomy\n* Valve-in-valve procedure\n* Severe calcification of the aortic annulus protruding into the left ventricular outflow tract and predisposing for annular rupture\n* Significant stenosis of the left main or proximal left anterior descending artery with substantial risk of hemodynamic instability during rapid ventricular pacing","ALL","65 Years",{"count":61,"type":62},146,"ESTIMATED","INTERVENTIONAL",[65],"NA","Asymmetrical and inadequate expansion of transcatheter heart valves (THVs) have been described as a key predictor of impaired valve hemodynamic performance predisposing patients for bioprosthetic valve dysfunction (BVD) and death. Post-dilatation using the original delivery system balloon at the identical filling volume after deployment of balloon-expandable THVs represents an invasive strategy to potentially optimize expansion and reduce asymmetry of balloon-expandable THVs. Currently, the efficacy and safety of routine post-dilatation has never been assessed in a randomized controlled fashion. The present randomized controlled DUOTAP trial aims to assess efficacy and safety of routine post-dilatation on THV expansion, hemodynamics, durability, and associated clinical outcomes in patients with severe aortic stenosis.",[68],"Aortic Valve Stenosis",[70,71,72,73,74],"Balloon-expandable TAVI prostheses","Fluoroscopic imaging","Computed tomography","Post-Dilatation","Double-Tap","2026-05-07",{"date":77,"type":78},"2026-05-12","ACTUAL",{"date":80,"type":78},"2025-01-01",{"date":82,"type":62},"2031-05",{"name":5,"class":6},1]