Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-28 @ 5:23 PM
Study NCT ID:
NCT05912660
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2023-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18882}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-10', 'studyFirstSubmitDate': '2023-06-10', 'studyFirstSubmitQcDate': '2023-06-10', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '10 years', 'description': 'all cause mortality after aortic valve replacement'}], 'secondaryOutcomes': [{'measure': 'reoperation', 'timeFrame': '10 years', 'description': 'incidence of reoperation after aortic valve replacement'}, {'measure': 'myocardial infaction', 'timeFrame': '10 years', 'description': 'incidence of myocardial infaction after aortic valve replacement'}, {'measure': 'heart failure', 'timeFrame': '10 years', 'description': 'incidence of heart failure after aortic valve replacement'}, {'measure': 'stroke', 'timeFrame': '10 years', 'description': 'incidence of stroke after aortic valve replacement'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Valve Disease']}, 'descriptionModule': {'briefSummary': 'The overall project aim is to study outcomes following aortic valve replacement with surgically implanted bioprostheses or TAVI by retrieving data from the main social security carriers in Austria for the years 2010-2020.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI) above 65 years of age with no other concomitant heart surgery and no coronary revascularization within 4 months before the index procedure were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI)\n\nExclusion Criteria:\n\n* below 65 years of age\n* coronary revascularization within 4 months before the index procedure\n* concomitant heart surgery'}, 'identificationModule': {'nctId': 'NCT05912660', 'briefTitle': 'Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis', 'orgStudyIdInfo': {'id': 'AUTHEARTVISIT - TAVI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aortic valve replacement with surgically implanted bioprostheses', 'interventionNames': ['Device: Aortic Valve Replacement']}, {'label': 'Aortic valve replacement with TAVI', 'interventionNames': ['Device: Aortic Valve Replacement']}], 'interventions': [{'name': 'Aortic Valve Replacement', 'type': 'DEVICE', 'description': 'Aortic Valve Replacement (surgically or TAVI)', 'armGroupLabels': ['Aortic valve replacement with TAVI', 'Aortic valve replacement with surgically implanted bioprostheses']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sicknessfund Burgenland', 'class': 'UNKNOWN'}, {'name': 'Landesklinikum Sankt Polten', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ. Prof. , MD, MBA', 'investigatorFullName': 'Hendrik Jan Ankersmit', 'investigatorAffiliation': 'Medical University of Vienna'}}}}