Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT01678456
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Registration and Assessment of Serious Adverse Events Within the AFNET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013575', 'term': 'Syncope'}], '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'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2012-08-31', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Critical Event Committee', 'Serious adverse events', 'Thromboembolic complications', 'Cardiac and noncardiac complications', 'Bleeding complications', 'Acute heart failure', 'Syncope', 'Resuscitation'], 'conditions': ['Atrial Fibrillation', 'Assessment of Serious Advers Events', 'Thromboembolic and Bleeding Complications', 'Complications of Antiarrhythmic Drugs or Invasive Procedures', 'Assessment by a Critical Event Committee']}, 'descriptionModule': {'briefSummary': 'Prospective registration and independent assessment of SAE associated with atrial fibrillation such as thromboembolic events, and other cardiac and noncardiac complications by a Critical Event Committee.', 'detailedDescription': 'Atrial fibrillation (AF), the most common sustained rhythm disturbance, is associated with a significantly enhanced mortality and morbidity due to thromboembolic events, and other cardiac and noncardiac complications. Therefore the "Network of Competence on Atrial Fibrillation (AFNET)" supported by the German Ministry for Education and Research (BMBF) was established in order to collect clinical data on patients (pts) with AF (paroxysmal, persistent, permanent) over a study period of 6 years with an expected sample size of 12,000 pts. Incidence, clinical relevance and outcome after SAE is recorded and assessed by a Critical Event Committee (CEC).\n\nThe CEC-members (experts in cardiology and neurology) defined as SAE any death with or without relationship to AF, cardio-embolic events (stroke, peripheral arterial embolism), bleeding complications due to antithrombotic therapy, acute heart failure, syncope, resuscitation; additionally, the complication of interventional strategies for AF-treatment and other AF-independent SAEs.\n\nOver a 3-year follow-up period, during 6-monthly and unscheduled visits, the SAEs are systematically documented, blinded and their relationship to AF will be interpreted in detail by the CEC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Real-life population Patients with atrial fibrilation documented within the last 12 months before enrollment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Atrial fibrillation documented by ECG not older then one year\n* Age \\> 18 years\n* Informed consent\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01678456', 'acronym': 'AFNET A7', 'briefTitle': 'Prospective Registration and Assessment of Serious Adverse Events Within the AFNET', 'organization': {'class': 'OTHER', 'fullName': 'Atrial Fibrillation Network'}, 'officialTitle': 'Prospective Registration and Independent Assessment of Incidence, Clinical Relevance and Outcome of Serious Adverse Events (SAE) Registered in the German Competence Network on Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'AFNET_A7'}}, 'contactsLocationsModule': {'locations': [{'zip': '14770', 'city': 'Brandenburg', 'country': 'Germany', 'facility': 'Staedt. Klinikum, Department of Cardiology', 'geoPoint': {'lat': 52.41667, 'lon': 12.55}}], 'overallOfficials': [{'name': 'Michael Oeff, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SAE-Zentrum Brandenburg/Havel Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atrial Fibrillation Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}