Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-31 @ 8:09 AM
Study NCT ID:
NCT05995561
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2023-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HERA FIb Registry for Patients With Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12297}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-08', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '24 months', 'description': 'all-cause mortality during follow-up'}], 'secondaryOutcomes': [{'measure': 'ischaemic stroke', 'timeFrame': '24 months', 'description': 'ischaemic stroke during follow-up'}, {'measure': 'major bleeding', 'timeFrame': '24 months', 'description': 'major bleeding during follow-up'}, {'measure': 'myocardial infarction', 'timeFrame': '24 months', 'description': 'myocardial infarction during follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '40033211', 'type': 'DERIVED', 'citation': 'Salbach C, Yildirim M, Hund H, Muller-Hennessen M, Frey N, Katus HA, Giannitsis E, Milles BR. Effect of non-invasive rhythm control on outcomes in patients with first diagnosed atrial fibrillation presenting to an emergency department. BMC Emerg Med. 2025 Mar 3;25(1):35. doi: 10.1186/s12873-025-01194-z.'}, {'pmid': '39921512', 'type': 'DERIVED', 'citation': 'Yildirim M, Milles BR, Hund H, Biener M, Muller-Hennessen M, Frey N, Katus HA, Giannitsis E, Salbach C. Outcomes and Disease Management in Patients With Atrial Fibrillation >/=80 Years: Data From a Consecutive 11-Year Real-World Registry. J Am Heart Assoc. 2025 Feb 18;14(4):e036832. doi: 10.1161/JAHA.124.036832. Epub 2025 Feb 8.'}, {'pmid': '38639359', 'type': 'DERIVED', 'citation': 'Salbach C, Yildirim M, Hund H, Biener M, Muller-Hennessen M, Frey N, Katus HA, Giannitsis E, Milles BR. Design, Rationale and Initial Findings From HERA-FIB on 10 222 Patients With Atrial Fibrillation Presenting to an Emergency Department Over An 11-Year Period. J Am Heart Assoc. 2024 May 7;13(9):e033396. doi: 10.1161/JAHA.123.033396. Epub 2024 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'The single-center HERA AFIb registry was created to assess real-world prevalence, demographic characteristics and management of patients with atrial fibrillation (AF) in the era of novel oral anticoagulant regimes (NOAC) presenting in the emergency department (ED) of University of Heidelberg', 'detailedDescription': 'HERA AFIb is a single-center retrospective registry which enrolled consecutive cases presenting with atrial fibrillation at the emergency department of University Hospital of Heidelberg. Clinical parameters and characteristics for cases were assessed retrospectively. Follow-up was performed via review of medical reports, phone calls and postal queries. Outcome parameters included rates for all-cause mortality, non-hemorrhagic stroke, myocardial infarction and major bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort of approximately 13000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* documented atrial fibrillation\n* availability of at least one hsTnT measurement\n\nExclusion Criteria:\n\n* lost to follow-up'}, 'identificationModule': {'nctId': 'NCT05995561', 'briefTitle': 'HERA FIb Registry for Patients With Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Heidelberg Registry of Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'HERA FIb registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'atrial fibrillation', 'description': 'cases presenting with atrial fibrillation at the emegency department.', 'interventionNames': ['Other: no intervention is planned.']}], 'interventions': [{'name': 'no intervention is planned.', 'type': 'OTHER', 'description': 'no intervention is planned.', 'armGroupLabels': ['atrial fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Hospital of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Mustafa Yildirim', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}