[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626025":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":30,"responsibleParty":74,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":12,"enrollmentInfo":92,"targetDuration":12,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":108,"whyStopped":12,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"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",[31,49,60],{"facility":32,"status":12,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Cabrini Hospital","Malvern","Victoria","3144","Australia","AU",{"type":39,"coordinates":40},"Point",[41,42],145.02811,-37.86259,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":47,"phoneExt":12,"email":48},"Shane Nanayakkara, MBBS PHD","+61395081222","S.Nanayakkara@alfred.org.au",{"facility":50,"status":12,"city":51,"state":34,"zip":52,"country":36,"countryCode":37,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"The Alfred Hospital","Melbourne","3004",{"type":39,"coordinates":54},[55,56],144.96332,-37.814,{"lat":56,"lon":55},[59],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},{"facility":61,"status":12,"city":62,"state":34,"zip":63,"country":36,"countryCode":37,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Epworth Hospital","Richmond","3121",{"type":39,"coordinates":65},[66,67],145.00176,-37.81819,{"lat":67,"lon":66},[70],{"name":71,"role":27,"phone":72,"phoneExt":12,"email":73},"Stephanie English, RN","+61 3 9426 6693","stephanie@tonywalton.com.au",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Nalin Dayawansa","Associate Investigator",[79],{"name":80,"class":81},"Edwards Lifesciences","INDUSTRY","100626025","dilation-optimisation-for-uniform-bioprosthetic-leaflet-expansion-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":93,"type":94},250,"ESTIMATED","INTERVENTIONAL",[97],"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.",[100,101],"Aortic Stenosis","TAVI(Transcatheter Aortic Valve Implantation)",[103,104,105,106,107],"TAVI","TAVR","Double Tap","balloon post-dilation","Balloon-expandable TAVI","NOT_YET_RECRUITING","2026-02-18",{"date":111,"type":112},"2026-02-24","ACTUAL",{"date":114,"type":94},"2026-04-01",{"date":116,"type":94},"2029-04-01",{"name":5,"class":6},3]