Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-02-02 @ 6:29 AM
Study NCT ID:
NCT00345592
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2006-06-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017147', 'term': 'Defibrillators, Implantable'}], 'ancestors': [{'id': 'D047548', 'term': 'Defibrillators'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gluca.botto@gmail.com', 'phone': '0315851', 'title': 'Giovanni Luca Botto', 'phoneExt': '+39', 'organization': 'S. Anna Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Device Managed Arm', 'description': 'Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.\n\nDual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.', 'otherNumAtRisk': 199, 'otherNumAffected': 39, 'seriousNumAtRisk': 199, 'seriousNumAffected': 103}, {'id': 'EG001', 'title': 'Traditional Arm', 'description': 'Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.\n\nDual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device\n\nDual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment', 'otherNumAtRisk': 197, 'otherNumAffected': 22, 'seriousNumAtRisk': 197, 'seriousNumAffected': 93}], 'otherEvents': [{'term': 'device reprogramming', 'notes': 'need to change device settings due to patient sysmptoms or adverse device effect, without invasive intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'clinical observation', 'notes': 'not requiring intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'worsening of cardiac disorders', 'notes': 'events leading to death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hopspitalizatin/intervention', 'notes': 'including cardiac and non cardiac hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 85, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 74, 'numAffected': 58}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'worsening of non-cardiac disorders', 'notes': 'events leading to death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'worsening of unknown conditions leading to death', 'notes': 'include all the events leading to out of hospital death for unknown or undetermined conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Managed Arm', 'description': 'Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.\n\nDual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.'}, {'id': 'OG001', 'title': 'Traditional Arm', 'description': 'Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.\n\nDual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device\n\nDual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.987', 'ciLowerLimit': '0.684', 'ciUpperLimit': '1.503', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 years from randomization (39 months total)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device Managed Arm', 'description': 'Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.\n\nDual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.'}, {'id': 'FG001', 'title': 'Traditional Arm', 'description': 'Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.\n\nDual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device\n\nDual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '197'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'First patient was enrolled on the 3rd of October, 2006. Last patient was enrolled on the 29th of July 2009, for a total of 420 patients.', 'preAssignmentDetails': '24 subjects were not randomized:\n\n* 7 died before randomization (causes: 3 cardiac, 2 non-cardiac, 2 unknown);\n* 7 voluntarily withdrew;\n* 5 withdrawn due to AF.\n* 2 had device explanted before randomization;\n* 1 had biventricular pacing turned OFF\n* 1 was withdrawn from the study for inclusion criteria violation;\n* 1 lost to follow up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Device Managed Arm', 'description': 'Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.\n\nDual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.'}, {'id': 'BG001', 'title': 'Traditional Arm', 'description': 'Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.\n\nDual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device\n\nDual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '10', 'groupId': 'BG000'}, {'value': '68', 'spread': '10', 'groupId': 'BG001'}, {'value': '67', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '199', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2006-06-27', 'resultsFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2006-06-27', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-13', 'studyFirstPostDateStruct': {'date': '2006-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation', 'timeFrame': '3 years from randomization (39 months total)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '21324118', 'type': 'DERIVED', 'citation': 'Botto GL, Boriani G, Favale S, Landolina M, Molon G, Tondo C, Biffi M, Grandinetti G, De Filippo P, Raciti G, Padeletti L. Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial. Trials. 2011 Feb 15;12:44. doi: 10.1186/1745-6215-12-44.'}]}, 'descriptionModule': {'briefSummary': 'Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment of symptomatic AT/AF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic symptomatic HF despite stable, optimal drug therapy\n* indication for a cardiac resynchronisation device with defibrillator backup according to current guidelines\n* patients implanted with cardiac resynchronization device with dual (atrial and ventricular) defibrillation capabilities\n\nExclusion Criteria:\n\n* Chronic atrial fibrillation\n* Valvular disease\n* patients who underwent or are planned for ablation of atrial fibrillation\n* cerebral vascular accident/transient ischemic attack within 12 months from implant which lead to relevant impairment\n* preexisting unipolar pacemaker'}, 'identificationModule': {'nctId': 'NCT00345592', 'acronym': 'TRADE HF', 'briefTitle': 'TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients', 'orgStudyIdInfo': {'id': '2005_TH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device managed arm', 'description': 'Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.', 'interventionNames': ['Device: Dual (atrial and ventricular) implantable defibrillator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional arm', 'description': 'Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.', 'interventionNames': ['Device: Dual (atrial and ventricular) implantable defibrillator']}], 'interventions': [{'name': 'Dual (atrial and ventricular) implantable defibrillator', 'type': 'DEVICE', 'description': 'The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.', 'armGroupLabels': ['Device managed arm']}, {'name': 'Dual (atrial and ventricular) implantable defibrillator', 'type': 'DEVICE', 'description': 'In hospital application of anti arrhythmic therapies via the device', 'armGroupLabels': ['Traditional arm']}, {'name': 'Dual (atrial and ventricular) implantable defibrillator', 'type': 'DEVICE', 'description': 'Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment', 'armGroupLabels': ['Traditional arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Careggi', 'country': 'Italy', 'facility': 'Istituto di Clinica Medica I° e Cardiologia A.O.C.', 'geoPoint': {'lat': 43.81284, 'lon': 11.25097}}, {'city': 'San Fermo Della Battaglia (CO)', 'country': 'Italy', 'facility': 'Azienda Ospedale S. Anna', 'geoPoint': {'lat': 45.80868, 'lon': 9.04744}}], 'overallOfficials': [{'name': 'Gianluca Botto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedale S. Anna'}, {'name': 'Luigi Padeletti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}