Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT04776759
Status:
RECRUITING
Last Update Posted:
2021-03-02
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2031-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of mortality, thromboembolic event and heart failure', 'timeFrame': 'at 10-year', 'description': 'Incidence of all-cause mortality, symptomatic thromboembolic event and congestive heart failure at 10-year after initial diagnosis of atrial fibrillation.'}, {'measure': 'Recurrent symptomatic atrial fibrillation.', 'timeFrame': 'at 10-year', 'description': 'Incidence of symptomatic atrial fibrillation at 10-year after initial diagnosis of atrial fibrillation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Lone Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation', 'Lone Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation is a rare cardiac arrhythmia in young (i.e. \\<= 35-year-old) patients. Etiological factors, current management and mid- to long-term outcomes remain unknown.', 'detailedDescription': 'Atrial Fibrillation in YOUNG patients (YOUNG-AF) is a prospective, observational, multicentric registry, including every consecutive patients aged \\< 35-year-old with a diagnosis of atrial fibrillation. The registry will assess demographical, physical activity, toxicologic and genetic factors, as well as current management regarding anticoagulation, anti-arrhythmic drugs and catheter ablation. As an observational registry, patient will be managed with the guidelines-directed standard-of-care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young patients (i.e. \\< or = to 35-year-old) at the time of first atrial fibrillation episode.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First episode of atrial fibrillation\n* Less than 35-year-old\n* Diagnostic by 12-lead ECG or continuous monitoring (minimal duration 30 seconds)\n* French Social Security number\n\nExclusion Criteria:\n\n* Transvenous cardiac implantable electronic device (insertable cardiac monitors are not an exclusion criteria)'}, 'identificationModule': {'nctId': 'NCT04776759', 'acronym': 'YOUNG-AF', 'briefTitle': 'Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry', 'orgStudyIdInfo': {'id': 'Rythmo20200901'}}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Normandy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre Ollitrault, MD, MSc', 'role': 'CONTACT', 'email': 'ollitrault-p@chu-caen.fr', 'phone': '0231063106'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Pierre Ollitrault, MD, MSc', 'role': 'CONTACT', 'email': 'ollitrault-p@chu-caen.fr', 'phone': '0231063106'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}