Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2026-01-28 @ 4:23 PM
Study NCT ID:
NCT01119716
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2010-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)
Sponsor:
Organization:
Raw JSON
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design, conduct, data interpretation and dissemination of study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'No formal reporting or recording of adverse events was conducted during this observational study.', 'eventGroups': [{'id': 'EG000', 'title': 'All Enrolled Participants', 'description': 'Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2909', 'groupId': 'OG000'}, {'value': '1740', 'groupId': 'OG001'}, {'value': '4649', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Male', 'description': 'Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG001', 'title': 'Female', 'description': 'Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG002', 'title': 'Total', 'description': 'All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}], 'classes': [{'title': 'Congenital Heart Disease', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Sick Sinus Syndrome', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}, {'value': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Sustained Ventricular Tachycardia', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '0.5', 'groupId': 'OG001'}, {'value': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Ventricular Fibrillation', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (time of admission)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with baseline cardiovascular history data.'}, {'type': 'PRIMARY', 'title': 'Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2851', 'groupId': 'OG000'}, {'value': '1711', 'groupId': 'OG001'}, {'value': '4562', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Male', 'description': 'Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG001', 'title': 'Female', 'description': 'Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG002', 'title': 'Total', 'description': 'All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}], 'classes': [{'title': 'Chronic Obstructive Pulmonary Disease', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '7.5', 'groupId': 'OG002'}]}]}, {'title': 'Peripheral Vascular Disease', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}]}]}, {'title': 'Chronic Renal Failure', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '6.2', 'groupId': 'OG002'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Sleep Apnea Syndrome', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '3.8', 'groupId': 'OG002'}]}]}, {'title': 'Haemorrhagic Complication', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (time of admission)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with co-morbity data available.'}, {'type': 'PRIMARY', 'title': 'Clinical Type of Atrial Fibrillation at Baseline (Admission)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2909', 'groupId': 'OG000'}, {'value': '1740', 'groupId': 'OG001'}, {'value': '4649', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Male', 'description': 'Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG001', 'title': 'Female', 'description': 'Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG002', 'title': 'Total', 'description': 'All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}], 'classes': [{'title': '1st Detected Episode', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '33.6', 'groupId': 'OG001'}, {'value': '30.8', 'groupId': 'OG002'}]}]}, {'title': 'Paroxysmal', 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}, {'value': '28.9', 'groupId': 'OG002'}]}]}, {'title': 'Persistent', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}, {'value': '33.1', 'groupId': 'OG002'}]}]}, {'title': 'Permanent', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '4.0', 'groupId': 'OG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}, {'value': '3.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (time of admission)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with admission (baseline) atrial fibrillation data available.'}, {'type': 'PRIMARY', 'title': 'Treatments Utilized for Participants for Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2916', 'groupId': 'OG000'}, {'value': '1742', 'groupId': 'OG001'}, {'value': '4658', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Male', 'description': 'Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG001', 'title': 'Female', 'description': 'Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG002', 'title': 'Total', 'description': 'All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}], 'classes': [{'title': 'Electrical Cardioversion', 'categories': [{'measurements': [{'value': '1677', 'groupId': 'OG000'}, {'value': '792', 'groupId': 'OG001'}, {'value': '2469', 'groupId': 'OG002'}]}]}, {'title': 'Pharmacological Cardioversion', 'categories': [{'measurements': [{'value': '705', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}, {'value': '1314', 'groupId': 'OG002'}]}]}, {'title': 'Combined Electrical/Pharmacological Cardioversion', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}]}, {'title': 'Rate Control Change', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}]}]}, {'title': 'Catheter Ablation', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}]}, {'title': 'Surgical Therapy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Implantable Cardiac Defibrillator', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Pacemaker', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'No Treatment', 'categories': [{'measurements': [{'value': '550', 'groupId': 'OG000'}, {'value': '342', 'groupId': 'OG001'}, {'value': '892', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of Treatment (up to 1 day from admission)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with available data pertaining to type of therapy(s) used to treat the participants atrial fibrillation.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2262', 'groupId': 'OG000'}, {'value': '1332', 'groupId': 'OG001'}, {'value': '3594', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Male', 'description': 'Male participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed'}, {'id': 'OG001', 'title': 'Female', 'description': 'Female participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed'}, {'id': 'OG002', 'title': 'Total', 'description': 'All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}], 'classes': [{'title': 'Electrical Cardioversion', 'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000'}, {'value': '55.1', 'groupId': 'OG001'}, {'value': '64.2', 'groupId': 'OG002'}]}]}, {'title': 'Pharmacological Cardioversion', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}, {'value': '35.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At time of treatment (up to 1 day from admission)', 'description': 'Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had artrial fibrillation treated by either electrical or pharmacological cardioversion.'}, {'type': 'PRIMARY', 'title': 'Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2633', 'groupId': 'OG000'}, {'value': '1507', 'groupId': 'OG001'}, {'value': '4140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Male', 'description': 'Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG001', 'title': 'Female', 'description': 'Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, {'id': 'OG002', 'title': 'Total', 'description': 'All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}], 'classes': [{'title': 'Myocardial Infarction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Non-haemorrhagic Stroke', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Haemorrhagic Stroke', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Peripheral Embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary Embolism', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Transient Ischaemic Attack', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Heart Failure', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Major Bleeding', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Minor Bleeding', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Recurrence of Atrial Fibrillation', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}]}, {'title': 'Recurrence of Atrial Flutter', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Asystole for more than 3 seconds', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Symptomatic Ventricular Tachycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ventricular Fibrillation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Sick Sinus syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Torsade de pointes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Syncope', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Endocarditis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Tamponade', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Hypotension', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Other Complication', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 60 days from day of treatment (cardioversion)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants with follow-up data available'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Enrolled Participants', 'description': 'Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4658'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4658'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4658', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Participants', 'description': 'Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1742', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2916', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4658}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2013-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2010-05-06', 'resultsFirstSubmitDate': '2013-12-13', 'studyFirstSubmitQcDate': '2010-05-06', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-13', 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)', 'timeFrame': 'Baseline (time of admission)'}, {'measure': 'Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)', 'timeFrame': 'Baseline (time of admission)'}, {'measure': 'Clinical Type of Atrial Fibrillation at Baseline (Admission)', 'timeFrame': 'Baseline (time of admission)'}, {'measure': 'Treatments Utilized for Participants for Atrial Fibrillation', 'timeFrame': 'At time of Treatment (up to 1 day from admission)'}, {'measure': 'Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion', 'timeFrame': 'At time of treatment (up to 1 day from admission)', 'description': 'Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered.'}, {'measure': 'Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation', 'timeFrame': 'up to 60 days from day of treatment (cardioversion)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Afib', 'cardioversion', 'normal sinus rhythm', 'arrhythmia', 'AF'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '24556445', 'type': 'RESULT', 'citation': 'Crijns HJ, Weijs B, Fairley AM, Lewalter T, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bash LD, Chazelle F, Bernhardt A, Gitt AK, Lip GY, Le Heuzey JY. Contemporary real life cardioversion of atrial fibrillation: Results from the multinational RHYTHM-AF study. Int J Cardiol. 2014 Apr 1;172(3):588-94. doi: 10.1016/j.ijcard.2014.01.099. Epub 2014 Jan 25.'}, {'pmid': '23031215', 'type': 'DERIVED', 'citation': 'Crijns HJ, Bash LD, Chazelle F, Le Heuzey JY, Lewalter T, Lip GY, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bernhardt AA, Unniachan S, Phatak HM, Gitt AK. RHYTHM-AF: design of an international registry on cardioversion of atrial fibrillation and characteristics of participating centers. BMC Cardiovasc Disord. 2012 Oct 2;12:85. doi: 10.1186/1471-2261-12-85.'}]}, 'descriptionModule': {'briefSummary': 'This study will create a prospective registry of consecutive patients with Atrial Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of in-hospital treatment, with a focus on the characterization of type of Afib, as well as on treatments applied (drugs, devices, interventions and their combinations), and associated complications within 60 days after enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in a hospital setting in Australia, Brazil, France, Germany, Italy, Netherlands, Poland, UK, Spain, and Sweden from a cross section of different centers including university and non-university hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant with documented atrial fibrillation (confirmed by electrocardiogram) in the hospital setting at the time of enrollment\n* Planned cardioversion (of atrial fibrillation)\n\nExclusion Criteria:\n\n* Already enrolled in this or any other clinical trial\n* Atrial flutter'}, 'identificationModule': {'nctId': 'NCT01119716', 'acronym': 'RHYTHM-AF', 'briefTitle': 'International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'International Registry on Cardioversion of Atrial Fibrillation', 'orgStudyIdInfo': {'id': '6621-051'}, 'secondaryIdInfos': [{'id': '2010_025'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Enrolled Participants', 'description': 'Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Institut für Herzinfarktforschung an der Universität Heidelberg', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}