Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT06782620
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2025-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3761}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'up to 12 years', 'description': 'overall Survival'}], 'secondaryOutcomes': [{'measure': 'reoperation-free survival', 'timeFrame': 'up to 12 years', 'description': 'reoperation-free survival after either biological or mechanical AVR'}, {'measure': 'reoperation', 'timeFrame': 'up to 12 years', 'description': 'reoperation after either biological or mechanical AVR'}, {'measure': 'MACEs', 'timeFrame': 'up to 12 years', 'description': 'MACEs after either biological or mechanical AVR'}, {'measure': 'heart failure', 'timeFrame': 'up to 12 years', 'description': 'heart failure after either biological or mechanical AVR'}, {'measure': 'embolic stroke or ICH', 'timeFrame': 'up to 12 years', 'description': 'embolic stroke or ICH after either biological or mechanical AVR'}, {'measure': 'myocardial infarction', 'timeFrame': 'up to 12 years', 'description': 'myocardial infarction after either biological or mechanical AVR'}, {'measure': 'non-embolic bleeding', 'timeFrame': 'up to 12 years', 'description': 'non-embolic bleeding after either biological or mechanical AVR'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aortic valve replacement', 'mechanical AVR', 'biological AVR'], 'conditions': ['Aortic Valve Replacement']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study o is to compare outcomes after either biological or mechanical aortic valve replacement. The main question it aims to answer:\n\nIs survival better after mechanical aortic valve replacement compared to biological aortic valve replacement? Are there less complications and reoperations after mechanical aortic valve replacement compared to biological aortic valve replacement? We perform a retrospective Data Collection of anonymized Austrian health insurance data.', 'detailedDescription': 'Objectives: In recent years, age recommendations for the utilization of biological prostheses rather than mechanical prostheses for surgical aortic valve replacement (sAVR) have been significantly reduced. This study evaluated survival rates, major adverse cardiac events (MACEs), and reoperation risks following surgical (sM-AVR) and biological (sB-AVR) AVR, with the aim of providing data to inform optimal prosthesis selection for middle-aged patients between 50 and 65 years.\n\nMethods: A population-based cohort study was conducted using data from the Austrian Health System from 2010 to 2020. Patients undergoing isolated sAVR (n=3761) were categorized into sM-AVR (n=1018) and sB-AVR (n=2743) groups. Propensity score matching (PSM) was applied to balance covariates. The primary endpoint was all-cause mortality. The secondary endpoints included MACEs, reoperation, stroke, bleeding, and post-reoperation survival. Outcomes were assessed using Cox regression and Kaplan-Meier analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* age between 50 and 65 years\n* st. p. isolated biological or mechanical aortic valve replacement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 50 and 65 years\n* st. p. isolated biological or mechanical aortic valve replacement\n\nExclusion Criteria:\n\n* transcatheter aortic valve implantation (TAVI; MEL codes DB025, DB026, DB021, or XN010) as index procedure\n* age \\<50 or \\>65 years\n* concomitant heart surgery or additional procedures during the index operation\n* patients receiving a coronary artery stent (MEL codes DD050 or DD060) within four months before AVR'}, 'identificationModule': {'nctId': 'NCT06782620', 'briefTitle': 'Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds: Results of the AUTHEARTVISIT Study', 'orgStudyIdInfo': {'id': 'GS1-EK-4/722-2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sB-AVR', 'description': 'Patients with biological Aortic valve replacement'}, {'label': 'sM-AVR', 'description': 'Patients with mechanical Aortic valve replacement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Hendrik J Ankersmit, Univ. Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Alissa Florian', 'investigatorFullName': 'Alissa Florian', 'investigatorAffiliation': 'Medical University of Vienna'}}}}