Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-28 @ 11:51 AM
Study NCT ID:
NCT05978466
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006470', 'term': 'Hemorrhage'}], '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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of Atrial fibrillation', 'timeFrame': 'From enrollment to 10- year study completion', 'description': 'The natural progression of the condition will be assessed per medical record review'}, {'measure': 'Number of participants who had thrombo-embolic event', 'timeFrame': 'From enrollment to 10- year study completion', 'description': 'All strokes, transient ischemic and systemic thrombo-embolic events'}, {'measure': 'Mortality', 'timeFrame': 'From enrollment to 10- year study completion', 'description': 'All cause death will be noted'}], 'secondaryOutcomes': [{'measure': 'Number of participants who have experienced bleeding', 'timeFrame': 'From enrollment to 10- year study completion', 'description': 'All bleeding events events will be will be assessed throughout the duration of the study per medical record review'}, {'measure': 'Number of patients who have had pro-arrhythmia events', 'timeFrame': 'From enrollment to 10- year study completion', 'description': 'All pro-arrhythmic events will be documented and assessed'}, {'measure': 'Number of patients who have had patient adherence events', 'timeFrame': 'From enrollment to 10- year study completion', 'description': 'Events relating to subject non-compliance of medications will be documented for the duration of the study per medical record review'}, {'measure': 'Treatment complication', 'timeFrame': 'From enrollment to 10- year study completion', 'description': 'All adverse outcomes/events related to routine standard of care treatments will be noted and assessed for the duration of the study per medical record review'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atrial arrhythmia', 'atrial fibrillation', 'stroke', 'bleeding', 'Left Atrial Appendage Occlusion'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.corvitascience.org', 'label': "Research foundation's website"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats place patients at increased risk of developing clots in their bloodstream that could potentially lead to stroke. Normal care is designed to help prevent this from happening and to lessen or eliminate the symptoms patients may have. There are many different types of AF as well as numerous ways in which a variety of patients are treated. The investigators are interested in gathering more information to better keep track of patient treatment patterns (trends) that may differ from physician to physician, hospital to hospital, medication to medication, patient to patient and if necessary, procedure to procedure.', 'detailedDescription': 'The objective of this research is to establish a contemporary and simple to construct AF management registry that expands progressively over the continuum of care for each individual patient. The registry will be used to determine the course and progression of AF management in preventing thrombo-embolic events using rhythm and rate control interventions.\n\nPrimary endpoints:\n\n1. Atrial fibrillation natural history\n2. Thrombo-embolic event\n3. Death\n\nSecondary endpoints:\n\n1. Bleeding\n2. Pro-arrhythmia\n3. Patient adherence\n4. Treatment complication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects with the diagnosis of atrial fibrillation can be enrolled into the study regardless of sex, age or medical history', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of valvular or non valvular atrial fibrillation\n2. ECG documented atrial fibrillation A. 12 lead B. Rhythm strip C. Event monitor D. Holter Monitor E. Implantable loop recorder\n\nExclusion Criteria:\n\n1. Age below 18 years.\n2. Clinical evidence that death within 6 months is possible\n3. Inability to consent to the research or sign a consent form\n4. Inability to follow up at the research clinic at least annually for continuity of AF care and management'}, 'identificationModule': {'nctId': 'NCT05978466', 'acronym': 'MANAGE-AF', 'briefTitle': 'MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)', 'organization': {'class': 'OTHER', 'fullName': 'CorVita Science Foundation'}, 'officialTitle': 'MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)', 'orgStudyIdInfo': {'id': '2017-CSF-00100'}}, 'contactsLocationsModule': {'locations': [{'zip': '60605', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edward Burke', 'role': 'CONTACT', 'email': 'eddie@corvitahealth.org', 'phone': '773-432-4888'}, {'name': 'Martin C Burke, DO', 'role': 'CONTACT', 'email': 'mburke@corvitahealth.org', 'phone': '773-432-4888'}, {'name': 'Martin C Burke, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CorVita Science Foundation (NFP)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Edward M Burke', 'role': 'CONTACT', 'email': 'eddie@corvitahealth.org', 'phone': '773-432-4888'}, {'name': 'Martin C Burke, DO', 'role': 'CONTACT', 'email': 'mburke@corvitahealth.org', 'phone': '773-432-4888'}], 'overallOfficials': [{'name': 'Martin C Burke, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Scientific Officer'}]}, 'ipdSharingStatementModule': {'url': 'http://www.corvitascience.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Intermittently over the next 10-15 years', 'ipdSharing': 'YES', 'description': 'We plan to publish the results or outcomes associated with this registry to major peer-reviewed journals, didactic or poster sessions at national/international medical conferences.', 'accessCriteria': 'Co-investigator who enrolls at least one patient'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CorVita Science Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}