Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-04-12 @ 7:28 PM
Study NCT ID:
NCT02121158
Status:
TERMINATED
Last Update Posted:
2024-07-31
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, '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': 'michael.wininger@va.gov', 'phone': '203-932-5711', 'title': 'Michael T. Wininger, Ph.D., Study Biostatistician', 'phoneExt': '3262', 'organization': 'VA Cooperative Studies Program Coordinating Center, West Haven, CT'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events were monitored from consent/baseline through 30 days after study exit, an average of 31 months. Non-Serious Adverse Events were monitored from consent/baseline through 30 days (30 days only, i.e. 30 days past consent [OMT arm] or 30 days past implantation [ICD arm]), i.e. 30 days for all participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Optimal Medical Therapy', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 1, 'seriousNumAtRisk': 85, 'deathsNumAffected': 23, 'seriousNumAffected': 67}, {'id': 'EG001', 'title': 'Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 6, 'seriousNumAtRisk': 82, 'deathsNumAffected': 20, 'seriousNumAffected': 62}], 'otherEvents': [{'term': 'Painful implant site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'New dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'seriousEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Infection (ICD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Infection (other)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Lead Alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Atrial fibrillation / Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'HF Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 54}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optimal Medical Therapy', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.'}, {'id': 'OG001', 'title': 'Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, starting from consent/baseline: average of 31 months.', 'description': 'All-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Minnesota Living With Heart Failure Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optimal Medical Therapy', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.'}, {'id': 'OG001', 'title': 'Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '26.5'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '37.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at 12-months post-randomization', 'description': 'Minnesota Living with Heart Failure questionnaire. MLHF scoring: 0 points = Best QOL, 105 points = Worst QOL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population differs from total number of study participants due to non-completion of the 12-month study visit, explained by either patient expiry or missed visit.'}, {'type': 'SECONDARY', 'title': 'Sudden Cardiac Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optimal Medical Therapy', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.'}, {'id': 'OG001', 'title': 'Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, starting from consent/baseline: average of 31 months.', 'description': 'Sudden Cardiac Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All-cause Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Optimal Medical Therapy', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.'}, {'id': 'OG001', 'title': 'Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7457', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.915', 'ciLowerLimit': '0.534', 'ciUpperLimit': '1.568', 'statisticalMethod': 'Cox Proportional Hazards', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Unadjusted'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, starting from consent/baseline: average of 31 months.', 'description': 'Number of participants hospitalized during study follow-up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Optimal Medical Therapy', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.'}, {'id': 'FG001', 'title': 'Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment at six Department of Veterans Affairs Medical Centers (VAMCs). Recruitment start: 8/6/2015 (4) 9/25/2015 (1) and 10/29/2015 (1). Recruitment terminated: 12/6/2016 (1) and 12/5/2019 (5).', 'preAssignmentDetails': 'None: Study design did not include significant events that occur after participant enrollment: no run-in phase, nor wash-out.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Optimal Medical Therapy', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.'}, {'id': 'BG001', 'title': 'Optimal Medical Therapy + Implantable Cardioverter Defibrillator (OMT + ICD)', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke + FDA-Approved implantable cardioverter defibrillator and leads.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '140', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association Class: I', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were evaluated for their NYHA class level according to the criteria adapted in Dolgin M, 1994 (Dolgin M Association NYH, Fox AC, Gorlin R, Levin RI, New York Heart Association. Criteria Committee. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994.).\n\nClass I = No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association Class: II', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were evaluated for their NYHA class level according to the criteria adapted in Dolgin M, 1994 (Dolgin M Association NYH, Fox AC, Gorlin R, Levin RI, New York Heart Association. Criteria Committee. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994.).\n\nClass II = Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association Class: III', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were evaluated for their NYHA class level according to the criteria adapted in Dolgin M, 1994 (Dolgin M Association NYH, Fox AC, Gorlin R, Levin RI, New York Heart Association. Criteria Committee. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994.).\n\nClass III = Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association Class: IV', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were evaluated for their NYHA class level according to the criteria adapted in Dolgin M, 1994 (Dolgin M Association NYH, Fox AC, Gorlin R, Levin RI, New York Heart Association. Criteria Committee. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels. 9th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994.).\n\nClass IV = Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-17', 'size': 2023382, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-11-03T10:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'whyStopped': 'Results of the pilot were not enough to justify the extension of the pilot. Results presented are from pilot.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2014-04-16', 'resultsFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2014-04-21', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-21', 'studyFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Through study completion, starting from consent/baseline: average of 31 months.', 'description': 'All-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Quality of Life - Minnesota Living With Heart Failure Questionnaire', 'timeFrame': 'Measured at 12-months post-randomization', 'description': 'Minnesota Living with Heart Failure questionnaire. MLHF scoring: 0 points = Best QOL, 105 points = Worst QOL.'}, {'measure': 'Sudden Cardiac Death', 'timeFrame': 'Through study completion, starting from consent/baseline: average of 31 months.', 'description': 'Sudden Cardiac Death'}, {'measure': 'All-cause Hospitalization', 'timeFrame': 'Through study completion, starting from consent/baseline: average of 31 months.', 'description': 'Number of participants hospitalized during study follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['CSP 592', 'ICD', 'cardiovascular', 'heart', 'aging', 'chronic diseases', 'multi-site trial', 'investigational device', 'cardiomyopathy', 'coronary artery disease', 'congestive heart failure', 'myocardial infarction', 'I-70', 'I70', 'elderly', 'defibrillator'], 'conditions': ['Cardiomyopathy', 'Coronary Artery Disease', 'Congestive Heart Failure', 'Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '38984364', 'type': 'RESULT', 'citation': 'Singh SN, Wininger M, Raitt M, Adabag S, Moore H, Rottman JN, Scrymgeour A, Zhang J, Zheng K, Guarino P, Kyriakides TC; I-70 Study Group; Johnson G, Williams A, Beed A, MacMurdy K, Saavedra P. Efficacy and safety of implantable cardioverter-defibrillator implantation in the elderly-The I-70 Study: A randomized clinical trial. Heart Rhythm O2. 2024 Apr 27;5(6):365-373. doi: 10.1016/j.hroo.2024.04.010. eCollection 2024 Jun.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death in patients 70 years and older. This study will assess the many competing factors involved with ICD implantation including 1) the impact on mortality, especially in the context of a declining rate of sudden death with advanced age, 2) the tolerability of the powerful therapeutic action of the device, and 3) the impact on quality of life.', 'detailedDescription': 'The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death (SCD) in patients 70 years and older. In particular, this study is designed to determine the comparative effectiveness of ICD, in addition to optimal medical therapy (OMT), in reducing all-cause mortality, versus OMT alone; OMT includes standard intervention for chronic heart failure patients, i.e. lifestyle modification, disease management, adoption of healthy diet and exercise practices, etcetera. One particularly important secondary objective is to assess treatment efficacy under the conditions of high versus low co-morbidity burden.\n\nParticipants will be randomized (1:1 ratio) to ICD + OMT or OMT alone, and stratified by participating site and co-morbidity level (Charlson score \\<3 versus 3+). Acute treatment visits will occur as clinically indicated and per local convention; follow-up will occur 1-4 months post-randomization (all participants), and not sooner than 30 days - and not later than 120 days post-implantation (ICD arm); regular follow-up will occur at 6 month intervals post-randomization until study close (all participants). All follow-up will be conducted centrally. Neither the participant nor treating clinician will be masked to treatment.\n\nPrimary Objective:\n\nThe primary objective of this study is to determine if a primary prevention strategy with ICD implantation in addition to optimal medical therapy (OMT) is effective in reducing all-cause mortality compared to OMT alone in patients 70 years of age and older who are eligible for ICD therapy according to current Centers for Medicare \\& Medicaid Services (CMS) criteria.\n\nPrimary Hypothesis:\n\nThe primary hypothesis of this study is that implantation of an ICD plus optimal medical therapy will reduce all-cause mortality in patients 70 years of age and older versus optimal medical therapy alone.\n\nSecondary Objectives:\n\n1. One secondary objective of this study is to ascertain whether age, co-morbidity burden, or age and burden together, are determinants in mortality outcomes in the OMT versus ICD + OMT group.\n2. An additional secondary objective of the study is to determine the effect of ICD implantation plus optimal medical therapy on quality of life among elderly patients compared with optimal medical therapy alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 70 years of age or older\n2. Eligible for ICD implementation according to the CMS criteria for primary prevention by one of the following conditions:\n\n 1. Documented prior MI and a measured left ventricular ejection fraction (LVEF) \\<=30% (includes New York Heart Association \\[NYHA\\] class I, II, or III)\n 2. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction \\<=35%, and inducible, sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) at electrophysiology (EP) study\n 3. Ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA class II and III heart failure, and measured LVEF \\<=35%\n 4. Non-ischemic dilated cardiomyopathy (NIDCM) \\> 3 months, NYHA Class II and III heart failure, and measured LVEF \\<=35%\n3. Stable condition on Optimal Medical Therapy\n4. Able and willing to provide informed consent to participate in this study\n\nExclusion Criteria:\n\n1. Enrolled in or planning to enroll in a conflicting trial\n2. Receiving a bi-ventricular ICD device\n3. New York Heart Association class IV heart failure\n4. Cardiogenic shock or symptomatic hypotension while in stable baseline rhythm,\n5. Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past 3 months\n6. An MI within the past 40 days\n7. Clinical symptoms or findings that would make them a candidate for coronary revascularization\n8. Irreversible brain damage from pre-existing cerebral disease\n9. Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year\n10. Circumstance that would prevent completion of the trial and follow-up activities, including medical condition'}, 'identificationModule': {'nctId': 'NCT02121158', 'acronym': 'I-70', 'briefTitle': 'Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'CSP #592 - Efficacy and Safety of ICD Implantation in the Elderly', 'orgStudyIdInfo': {'id': '592'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'ICD implantation in addition to Optimal Medical Therapy', 'interventionNames': ['Device: Implantable Cardioverter Defibrillator']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Optimal Medical Therapy', 'interventionNames': ['Other: Optimal Medical Therapy']}], 'interventions': [{'name': 'Implantable Cardioverter Defibrillator', 'type': 'DEVICE', 'description': 'The ICD and lead(s) will be FDA-approved.', 'armGroupLabels': ['1']}, {'name': 'Optimal Medical Therapy', 'type': 'OTHER', 'description': 'Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20422-0001', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington DC VA Medical Center, Washington, DC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida/South Georgia Veterans Health System, Gainesville, FL', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Health Care System, Minneapolis, MN', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System, Portland, OR', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37212-2637', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Valley Healthcare System Nashville Campus, Nashville, TN', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Steve Singh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Washington DC VA Medical Center, Washington, DC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}