[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626025":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":30,"responsibleParty":73,"collaborators":77,"id":81,"slug":12,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":12,"enrollmentInfo":90,"targetDuration":12,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":106,"whyStopped":12,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"The Alfred","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Routine deployment","NO_INTERVENTION","Participants in the routine deployment arm will have no further post-dilation after satisfactory initial deployment of the balloon-expandable THV",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Routine double tap","EXPERIMENTAL","Participants in the double tap arm will undergo a second inflation of the delivery system balloon at the same filll volume after satisfactory initial deployment of the balloon-expandable THV",[18],"Other: 'Double tap' balloon post-dilation",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"'Double tap' balloon post-dilation","Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI",[14],[25],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Nalin H Dayawansa, MBBS","CONTACT","+61390765784","na.dayawansa@alfred.org.au",[31,48,59],{"facility":32,"status":12,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Cabrini Hospital","Malvern","Victoria","3144","Australia",{"type":38,"coordinates":39},"Point",[40,41],145.02811,-37.86259,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":46,"phoneExt":12,"email":47},"Shane Nanayakkara, MBBS PHD","+61395081222","S.Nanayakkara@alfred.org.au",{"facility":49,"status":12,"city":50,"state":34,"zip":51,"country":36,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"The Alfred Hospital","Melbourne","3004",{"type":38,"coordinates":53},[54,55],144.96332,-37.814,{"lat":55,"lon":54},[58],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},{"facility":60,"status":12,"city":61,"state":34,"zip":62,"country":36,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Epworth Hospital","Richmond","3121",{"type":38,"coordinates":64},[65,66],145.00176,-37.81819,{"lat":66,"lon":65},[69],{"name":70,"role":27,"phone":71,"phoneExt":12,"email":72},"Stephanie English, RN","+61 3 9426 6693","stephanie@tonywalton.com.au",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Nalin Dayawansa","Associate Investigator",[78],{"name":79,"class":80},"Edwards Lifesciences","INDUSTRY","100626025",false,"NCT07430267","Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion","Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial","ACE-DOUBLE","Inclusion Criteria:\n\n* Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra\u002FRESILIA balloon-expandable transcatheter heart valve.\n* Tricuspid or bicuspid aortic valve stenosis\n\nExclusion Criteria:\n\n* Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure\n* TAVI performed for native valve aortic regurgitation\n* High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy.","ALL","18 Years",{"count":91,"type":92},250,"ESTIMATED","INTERVENTIONAL",[95],"NA","The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN balloon-expandable TAVI prosthesis.\n\nThe primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance.\n\nParticipants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.",[98,99],"Aortic Stenosis","TAVI(Transcatheter Aortic Valve Implantation)",[101,102,103,104,105],"TAVI","TAVR","Double Tap","balloon post-dilation","Balloon-expandable TAVI","NOT_YET_RECRUITING","2026-02-18",{"date":109,"type":110},"2026-02-24","ACTUAL",{"date":112,"type":92},"2026-04-01",{"date":114,"type":92},"2029-04-01",{"name":5,"class":6},3]