Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT00933634
Status:
COMPLETED
Last Update Posted:
2009-07-07
First Post:
2009-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2010-07-29', 'releaseDate': '2009-07-14'}], 'estimatedResultsFirstSubmitDate': '2009-07-14'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004554', 'term': 'Electric Countershock'}, {'id': 'D011405', 'term': 'Propafenone'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-02', 'studyFirstSubmitDate': '2009-07-02', 'studyFirstSubmitQcDate': '2009-07-02', 'lastUpdatePostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm', 'timeFrame': 'during emergency department stay'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events related to electrical and pharmacological cardioversion', 'timeFrame': 'during emergency department stay'}, {'measure': 'recurrence of atrial fibrillation', 'timeFrame': 'within 2 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'electrical cardioversion', 'pharmacological cardioversion'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '21422032', 'type': 'DERIVED', 'citation': 'Bellone A, Etteri M, Vettorello M, Bonetti C, Clerici D, Gini G, Maino C, Mariani M, Natalizi A, Nessi I, Rampoldi A, Colombo L. Cardioversion of acute atrial fibrillation in the emergency department: a prospective randomised trial. Emerg Med J. 2012 Mar;29(3):188-91. doi: 10.1136/emj.2010.109702. Epub 2011 Mar 21.'}]}, 'descriptionModule': {'briefSummary': "The optimal strategy to restore sinus rhythm in patients with atrial fibrillation (AF) of less than 48 hours' duration is still controversial. The investigators performed a controlled single-center trial to compare electrical and pharmacological (propafenone) cardioversion to restore the sinus rhythm in selected patients with acute atrial fibrillation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* atrial fibrillation of less than 48 hours' duration.\n\nExclusion Criteria:\n\n* AF of more than 48 hours'\n* hemodynamic instability\n* acute onset atrial fibrillation due to acute coronary syndrome\n* electrolyte disturbances\n* sepsis\n* fever\n* hypothermia\n* untreated hyperthyroidism\n* use of antiarrhythmic drugs\n* high embolic risk\n* unclear duration of symptoms"}, 'identificationModule': {'nctId': 'NCT00933634', 'briefTitle': 'Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Valduce Hospital'}, 'officialTitle': 'Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ECVPCV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'electrical cardioversion', 'description': 'Patients were sedated with propofol and external cardioversion was performed in anteroposterior position (right sternal body at the third intercostal space-angle of the left scapula). Patients were submitted to a biphasic wave-form sequential shock of 100-150-200 J, if necessary.', 'interventionNames': ['Procedure: electrical cardioversion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'propafenone', 'description': 'Propafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion.', 'interventionNames': ['Drug: propafenone']}], 'interventions': [{'name': 'electrical cardioversion', 'type': 'PROCEDURE', 'description': 'External cardioversion was performed in anteroposterior position (right sternal body at the third intercostal space-angle of the left scapula); patients were submitted to a biphasic wave-form sequential shock of 100-150-200 J, if necessary.', 'armGroupLabels': ['electrical cardioversion']}, {'name': 'propafenone', 'type': 'DRUG', 'description': 'Propafenone (2 mg/kg bolus) was administered to obtain pharmacolgic sinus rhythm conversion.', 'armGroupLabels': ['propafenone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22100', 'city': 'Como', 'country': 'Italy', 'facility': 'Emergency Unit - Valduce Hospital', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valduce Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Andrea Bellone', 'oldOrganization': 'Valduce Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2009-07-14', 'type': 'RELEASE'}, {'date': '2010-07-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Valduce Hospital (Andrea Bellone)'}}}}