Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-13 @ 9:32 PM
Study NCT ID:
NCT02132767
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2014-05-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
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Gelijns, PhD', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin', 'otherNumAtRisk': 262, 'otherNumAffected': 29, 'seriousNumAtRisk': 262, 'seriousNumAffected': 71}, {'id': 'EG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.', 'otherNumAtRisk': 261, 'otherNumAffected': 26, 'seriousNumAtRisk': 261, 'seriousNumAffected': 73}], 'otherEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Cardiac Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Cardiac disorders'}, {'term': 'Major infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Renal events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Superficial venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Thrombophlebitis left limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Cardiac Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cerebrovascular Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Cardiac disorders'}, {'term': 'Major Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 28, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Infections and infestations'}, {'term': 'Non-Cerebral Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Pericardial Fluid Collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Renal Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Coumadin Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hypotension/Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Amiodarone Toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Abdominal Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Fall Not Related to Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Heparin-Induced Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Ischemic Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nosocomial Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Peripheral Arterial Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Peripheral Vascular Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Peripheral Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Right Groin Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Sternal Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Post-Pericardiotomy Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Small Bowel Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Non-Cerebral Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 262, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 261, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Days in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'OG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '7.4'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '7.5'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 60 days of randomization', 'description': 'The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients (intent to treat)'}, {'type': 'SECONDARY', 'title': 'Time to Conversion to Sustained, Stable Non-AF Rhythm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'OG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.85', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '4.81'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.27', 'upperLimit': '3.21'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to index hospital discharge or 7 days post surgery, whichever came first', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients (intent to treat)'}, {'type': 'SECONDARY', 'title': 'Heart Rhythm Comparison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'OG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}], 'classes': [{'categories': [{'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Hospital discharge', 'description': 'Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rhythm Comparison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'OG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}], 'classes': [{'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '30 days after randomization', 'description': 'Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Heart Rhythm Comparison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'OG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}], 'classes': [{'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '60 days after randomization', 'description': 'Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay (Index Hospitalization)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'OG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '6.6'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 60 days post surgery', 'description': 'Overall length of stay for the index hospitalization', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay (Rehospitalization, Including ED Visits)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'OG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '5.0'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.7'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 60 days of randomization', 'description': 'Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Outpatient Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'OG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 60 days of randomization', 'description': 'Compare frequency of outpatient visits between groups for any cause and AF-related causes', 'unitOfMeasure': 'hospital stays < 24 hours', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AF- or Treatment-related Events', 'timeFrame': 'Within 60 days of randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Cost (Hospital)', 'timeFrame': 'Within 60 days of randomization', 'description': 'Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'FG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}, {'groupId': 'FG001', 'numSubjects': '261'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '245'}, {'groupId': 'FG001', 'numSubjects': '246'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '523', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rate Control', 'description': 'Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is \\< 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (\\<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.\n\nRate Control Agents:\n\nBeta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin'}, {'id': 'BG001', 'title': 'Rhythm Control', 'description': 'Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.\n\nIf AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '68.8', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '242', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '492', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '462', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized patients'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 523}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2014-05-05', 'resultsFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2014-05-05', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-21', 'studyFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Days in Hospital', 'timeFrame': 'Within 60 days of randomization', 'description': 'The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.'}], 'secondaryOutcomes': [{'measure': 'Time to Conversion to Sustained, Stable Non-AF Rhythm', 'timeFrame': 'Up to index hospital discharge or 7 days post surgery, whichever came first'}, {'measure': 'Heart Rhythm Comparison', 'timeFrame': 'Hospital discharge', 'description': 'Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge'}, {'measure': 'Heart Rhythm Comparison', 'timeFrame': '30 days after randomization', 'description': 'Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization'}, {'measure': 'Heart Rhythm Comparison', 'timeFrame': '60 days after randomization', 'description': 'Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization'}, {'measure': 'Length of Stay (Index Hospitalization)', 'timeFrame': 'Within 60 days post surgery', 'description': 'Overall length of stay for the index hospitalization'}, {'measure': 'Length of Stay (Rehospitalization, Including ED Visits)', 'timeFrame': 'Within 60 days of randomization', 'description': 'Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits'}, {'measure': 'Outpatient Interventions', 'timeFrame': 'Within 60 days of randomization', 'description': 'Compare frequency of outpatient visits between groups for any cause and AF-related causes'}, {'measure': 'AF- or Treatment-related Events', 'timeFrame': 'Within 60 days of randomization'}, {'measure': 'Cost (Hospital)', 'timeFrame': 'Within 60 days of randomization', 'description': 'Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart surgery', 'Cardiac surgery', 'Coronary artery bypass', 'Mitral valve surgery', 'Aortic valve surgery', 'Atrial fibrillation', 'Atrial flutter', 'Cardiac arrhythmia', 'Valve surgery'], 'conditions': ['Postoperative Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '29043263', 'type': 'DERIVED', 'citation': 'Afifi A. CTS trials network: Rate control vs rhythm control for atrial fibrillation after cardiac surgery - Do bitter pills have blessed effects? Glob Cardiol Sci Pract. 2016 Jun 30;2016(2):e201615. doi: 10.21542/gcsp.2016.15.'}, {'pmid': '27043047', 'type': 'DERIVED', 'citation': "Gillinov AM, Bagiella E, Moskowitz AJ, Raiten JM, Groh MA, Bowdish ME, Ailawadi G, Kirkwood KA, Perrault LP, Parides MK, Smith RL 2nd, Kern JA, Dussault G, Hackmann AE, Jeffries NO, Miller MA, Taddei-Peters WC, Rose EA, Weisel RD, Williams DL, Mangusan RF, Argenziano M, Moquete EG, O'Sullivan KL, Pellerin M, Shah KJ, Gammie JS, Mayer ML, Voisine P, Gelijns AC, O'Gara PT, Mack MJ; CTSN. Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery. N Engl J Med. 2016 May 19;374(20):1911-21. doi: 10.1056/NEJMoa1602002. Epub 2016 Apr 4."}], 'seeAlsoLinks': [{'url': 'http://www.ctsurgerynet.org/', 'label': 'Cardiothoracic Surgical Trials Network Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the therapeutic strategies of rate control versus rhythm control in cardiac surgery patients who develop in-hospital postoperative atrial fibrillation or atrial flutter (AF). In patients who develop AF during hospitalization after cardiac surgery, the hypothesis is that a strategy of rhythm control will reduce days in hospital within 60 days of the occurrence of AF compared to a strategy of rate control.', 'detailedDescription': 'The purpose of the research is to compare two strategies for treating atrial fibrillation or atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is the most common complication after cardiac surgery. AF is when the upper chambers of the heart (atria) experience disorganized electrical activity which causes the heart beat to be irregular. The two treatment strategies to be used in this study are called rhythm control and rate control. The rhythm control strategy will attempt to bring the heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. The rate control strategy will attempt to bring the heart rate to less than 100 beats per minute at rest using medications known and recommended to control heart rate. Both strategies are commonly used to treat AF. All of the medications that will be used in this study are the standard of care for use in patients experiencing AF. This research seeks to determine whether rhythm control is better than rate control in patients with AF after cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Enrollment Inclusion Criteria:\n\n* Age \\> 18 years\n* Undergoing heart surgery for coronary artery bypass (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations\n* Hemodynamically stable\n\nRandomization Inclusion Criteria\n\n* AF that persists for \\> 60 minutes or recurrent (more than one) episodes of AF up to 7 days after surgery during the index hospitalization.\n\nExclusion Criteria:\n\n* LVAD insertion or heart transplantation\n* Maze procedure\n* TAVR\n* History of or planned mechanical valve replacement\n* Correction of complex congenital cardiac defect (excluding bicuspid aortic valve, atrial septal defect or PFO)\n* History of AF or AFL\n* History of AF or AFL ablation\n* Contraindications to warfarin or amiodarone\n* Need for long-term anticoagulation\n* Concurrent participation in an interventional (drug or device) trial'}, 'identificationModule': {'nctId': 'NCT02132767', 'briefTitle': 'Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'GCO 08-1078-00007'}, 'secondaryIdInfos': [{'id': '5U01HL088942-08', 'link': 'https://reporter.nih.gov/quickSearch/5U01HL088942-08', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rhythm control', 'description': 'Rhythm Control in post-operative AF\n\nAmiodarone and/or DC-cardioversion\n\nAmiodarone Initial Dose\n\n* Oral: 400 mg po TID for 3 days is recommended\n* For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose\n* Oral: at least 200 mg/day to be continued until 60 days after randomization\n* If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started\n\nDC-Cardioversion - frequency and duration determined by medical professional as medically needed', 'interventionNames': ['Drug: Amiodarone', 'Procedure: DC-cardioversion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rate control', 'description': 'Rate Control in post-operative AF\n\nBeta-blocker and/or Calcium channel blockers and/or Digoxin\n\nDose, frequency and duration determined by medical professional as medically needed', 'interventionNames': ['Drug: Rate Control']}], 'interventions': [{'name': 'Amiodarone', 'type': 'DRUG', 'otherNames': ['Cordarone'], 'description': 'Amiodarone Initial Dose\n\n* Oral: 400 mg po TID for 3 days is recommended\n* For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose\n* Oral: at least 200 mg/day to be continued until 60 days after randomization\n* If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started', 'armGroupLabels': ['Rhythm control']}, {'name': 'DC-cardioversion', 'type': 'PROCEDURE', 'otherNames': ['Direct Current Cardioversion'], 'description': 'DC-Cardioversion - frequency and duration determined by medical professional as medically needed', 'armGroupLabels': ['Rhythm control']}, {'name': 'Rate Control', 'type': 'DRUG', 'otherNames': ['Beta-blocker', 'Calcium channel blockers', 'Digoxin'], 'description': 'Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed', 'armGroupLabels': ['Rate control']}]}, 'contactsLocationsModule': 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'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie de Quebec (Hopital Laval)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Richard Wiesel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiothoracic Surgical Trials Network'}, {'name': "Patrick T O'Gara, MD", 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiothoracic Surgical Trials Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair, Health Evidence and Policy', 'investigatorFullName': 'Annetine 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