Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:36 AM
Study NCT ID:
NCT07430267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Imaging analysis will be performed by investigators blinded to treatment allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'CT sub-study: final valve expansion measured by non-contrast computed tomography', 'timeFrame': '30-90 days post-procedure', 'description': 'CT sub-study: final valve expansion (%) measured by non-contrast computed tomography'}, {'measure': 'New permanent pacemaker implantation', 'timeFrame': '30 days post-procedure', 'description': 'New permanent pacemaker implantation'}, {'measure': 'Stroke', 'timeFrame': '30 days post-procedure', 'description': 'Confirmed stroke'}], 'primaryOutcomes': [{'measure': 'Fluoroscopic valve expansion', 'timeFrame': 'Day 1 post-procedure', 'description': 'Percentage (%) final valve expansion measured by fluoroscopy'}], 'secondaryOutcomes': [{'measure': 'Haemodynamic performance', 'timeFrame': 'Day 1-3 post-procedure', 'description': 'Echocardiographic transvalvular mean pressure gradient (mmHg)'}, {'measure': 'Haemodynamic performance', 'timeFrame': 'Day 1-3 post-procedure', 'description': 'Echocardiographic aortic valve area (cmsq)'}, {'measure': 'Freedom from cardiovascular death or valve reintervention', 'timeFrame': '1 year and 3 years post-procedure', 'description': 'Freedom from occurrence of composite of cardiovascular death or valve reintervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAVI', 'TAVR', 'Double Tap', 'balloon post-dilation', 'Balloon-expandable TAVI'], 'conditions': ['Aortic Stenosis', 'TAVI(Transcatheter Aortic Valve Implantation)']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial comparing routine versus discretionary balloon post-dilation strategies following TAVI using the SAPIEN 3 balloon-expandable THV for severe aortic stenosis (AS).\n\nPatients with severe symptomatic aortic valve disease that are accepted for TAVI using a balloon-expandable THV. Currently, the only balloon-expandable THV in routine clinical practice in Australia are the Sapien 3 Ultra and Sapien 3 Ultra Resilia (Edwards Lifesciences, Irvine CA, USA). Patients will be recruited from three TAVI centres participating in the ACE registry: The Alfred Hospital, Cabrini Hospital and Epworth Hospital are all located in Melbourne, Australia.\n\nSpecific sub-groups may benefit more from balloon post-dilation (BPD), and hence exploratory analyses will be performed to examine the effect of BPD on primary endpoints in the following subgroups:\n\n* Male vs Female\n* Pre-dilation vs no pre-dilation\n* Tricuspid vs bicuspid aortic valve\n* Very severe AS (mean pressure gradient \\> 50mmHg)\n* Very aortic valve high calcium score (\\>3000 in males, \\>1900 in females)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA 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."}, 'identificationModule': {'nctId': 'NCT07430267', 'acronym': 'ACE-DOUBLE', 'briefTitle': 'Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial', 'orgStudyIdInfo': {'id': '058-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine deployment', 'description': 'Participants in the routine deployment arm will have no further post-dilation after satisfactory initial deployment of the balloon-expandable THV'}, {'type': 'EXPERIMENTAL', 'label': 'Routine double tap', 'description': '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', 'interventionNames': ["Other: 'Double tap' balloon post-dilation"]}], 'interventions': [{'name': "'Double tap' balloon post-dilation", 'type': 'OTHER', 'description': "Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI", 'armGroupLabels': ['Routine double tap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3144', 'city': 'Malvern', 'state': 'Victoria', 'country': 'Australia', 'contacts': [{'name': 'Shane Nanayakkara, MBBS PHD', 'role': 'CONTACT', 'email': 'S.Nanayakkara@alfred.org.au', 'phone': '+61395081222'}], 'facility': 'Cabrini Hospital', 'geoPoint': {'lat': -37.86259, 'lon': 145.02811}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'contacts': [{'name': 'Nalin H Dayawansa, MBBS', 'role': 'CONTACT', 'email': 'na.dayawansa@alfred.org.au', 'phone': '+61390765784'}], 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'country': 'Australia', 'contacts': [{'name': 'Stephanie English, RN', 'role': 'CONTACT', 'email': 'stephanie@tonywalton.com.au', 'phone': '+61 3 9426 6693'}], 'facility': 'Epworth Hospital', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}], 'centralContacts': [{'name': 'Nalin H Dayawansa, MBBS', 'role': 'CONTACT', 'email': 'na.dayawansa@alfred.org.au', 'phone': '+61390765784'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data cannot be released without specific approval from the HREC committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'collaborators': [{'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Investigator', 'investigatorFullName': 'Nalin Dayawansa', 'investigatorAffiliation': 'The Alfred'}}}}