Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 4:51 AM
Study NCT ID:
NCT06248294
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2024-01-20', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute difference in maximum aortic diameters at multiple levels of ascending aorta', 'timeFrame': '5 years', 'description': 'Measurements of maximum aortic diameters at follow-up CTA assessment will be compared with values at pre-TAVI CTA assessment'}], 'secondaryOutcomes': [{'measure': 'Death, stroke or rehospitalization for heart failure', 'timeFrame': '5 years', 'description': 'Death, stroke or rehospitalization for heart failure'}, {'measure': 'Aortic events leading to urgent intervention or elective aortic root replacement', 'timeFrame': '5 years', 'description': 'Aortic events (i.e. fissuration, dissection) after the index intervention leading to aortic intervention, or elective aortic root replacement.'}, {'measure': 'Bioprosthesis dysfunction (HALT or RLM at 4-D CTA assessment)', 'timeFrame': '5 years', 'description': 'Presence of hypo-attenuated leaflet thickening (HALT)/reduced leaflet motion (RLM) at follow-up four-dimensional CTA assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BAV', 'TAVI', 'Aortopathy'], 'conditions': ['Bicuspid-related Aortopathy', 'Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery. Although historically excluded from the main randomized clinical trials, patients with native bicuspid aortic valve (BAV) are commonly treated in daily TAVI practice. Indeed, several observational studies reported similar outcomes of TAVI in BAV patients compared to tricuspid aortic valve (TAV) patients. Notably, BAV is frequently associated with aortic dilatation (20% to 84% of BAV patients). Surgical patients usually undergo concomitant aortic root replacement if aortic diameter exceed 50 mm (5). TAVI patients do not undergo treatment of the concomitant aortopathy, but currently there is a paucity of data regarding the progression of the aortopathy after AS treatment (6,7).\n\nThe main aim of this ambispective, multicenter study is to evaluate the progression of the bicuspid valve-associated aortopathy in patients undergoing TAVI by computed tomography angiography (CTA) assessment at follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing TAVI with native BAV from January 2018 to December 2019\n\nExclusion Criteria:\n\n* Patients undergoing TAVI without native BAV\n* Patients receiving first generation TAVI device\n* Patients undergoing TAVI before January 2018 or after December 2019'}, 'identificationModule': {'nctId': 'NCT06248294', 'acronym': 'PROSPERO-TAVI', 'briefTitle': 'PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation: The PROSPERO-TAVI Multi Center, International Registry', 'orgStudyIdInfo': {'id': 'UCatania003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAVI patients with native BAV', 'description': 'Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve', 'interventionNames': ['Diagnostic Test: CT follow-up']}], 'interventions': [{'name': 'CT follow-up', 'type': 'DIAGNOSTIC_TEST', 'description': 'Computed tomography angiography assessment of BAV-related aorthopathy', 'armGroupLabels': ['TAVI patients with native BAV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95123', 'city': 'Catania', 'country': 'Italy', 'contacts': [{'name': 'Giuliano Costa, MD', 'role': 'CONTACT', 'email': 'giulianocosta90@gmail.com', 'phone': '393472187329'}, {'name': 'Marco Barbanti, MD', 'role': 'CONTACT', 'email': 'mbarbanti83@gmail.com', 'phone': '393283026464'}], 'facility': 'AOU Policlinico G. Rodolico - San Marco', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'centralContacts': [{'name': 'Giuliano Costa, MD', 'role': 'CONTACT', 'email': 'giulianocosta90@gmail.com', 'phone': '3934721874329'}, {'name': 'Marco Barbanti, MD', 'role': 'CONTACT', 'email': 'mbarbanti83@gmail.com', 'phone': '393283026464'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giuliano Costa', 'investigatorAffiliation': 'University of Catania'}}}}