Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-04-17 @ 12:33 AM
Study NCT ID:
NCT01966458
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2013-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.a.vassiliades@medtronic.com', 'phone': '+15085321942', 'title': 'Thomas Vassiliades', 'organization': 'Medtronic'}, 'certainAgreement': {'otherDetails': "In most cases, the contract allows the principal investigator to publish their data after the release of the multi-center publication (or one year after the conclusion of the study if no multi-center publication is submitted) following the sponsor review for (a) disclosure of confidential information, and (b) information that would impair the sponsor's ability to obtain patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events are summarized from the date of implant through 12 months while on the originally implanted device. Subjects are analyzed based on the device they actually received.', 'description': 'The Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) adverse event definitions are geared towards subjects who have a mechanically circulatory support device.', 'eventGroups': [{'id': 'EG000', 'title': 'HeartWare® VAS', 'description': 'Implant of HeartWare® Ventricular Assist System\n\nHeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.', 'otherNumAtRisk': 308, 'deathsNumAtRisk': 308, 'otherNumAffected': 95, 'seriousNumAtRisk': 308, 'deathsNumAffected': 56, 'seriousNumAffected': 295}, {'id': 'EG001', 'title': 'Control LVAD', 'description': 'Implant of FDA-approved LVAD approved for destination therapy\n\nControl LVAD: Any FDA-approved LVAD for destination therapy.', 'otherNumAtRisk': 157, 'deathsNumAtRisk': 157, 'otherNumAffected': 40, 'seriousNumAtRisk': 157, 'deathsNumAffected': 31, 'seriousNumAffected': 152}], 'otherEvents': [{'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Device Malfunction/Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Major Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 41, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 32, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Other Intermacs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}], 'seriousEvents': [{'term': 'Major Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 297, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 190, 'numAffected': 87}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Cardiac Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 132, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 49, 'numAffected': 42}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Device Malfunction/Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 81, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 46, 'numAffected': 38}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Hepatic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Major Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 259, 'numAffected': 150}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 149, 'numAffected': 85}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Neurological Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 83, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Pericardial Fluid Collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Psychiatric Episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Renal Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 74, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 37, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Right Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 101, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 61, 'numAffected': 56}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Arterial Non-CNS Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Venous Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}, {'term': 'Other Intermacs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numEvents': 599, 'numAffected': 219}, {'groupId': 'EG001', 'numAtRisk': 157, 'numEvents': 265, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Intermacs Ver. 3.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Neurologic Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HeartWare® VAS', 'description': 'HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.'}, {'id': 'OG001', 'title': 'Control LVAD', 'description': 'Control LVAD: Any FDA-approved LVAD for destination therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1444', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.6', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '10.7', 'estimateComment': 'Difference = HeartWare® VAS incidence rate - Control incidence rate Two-sided 90% exact binomial confident interval is used.', 'groupDescription': 'The primary endpoint is a non-inferiority test comparing HeartWare® VAS to Control.', 'statisticalMethod': 'Farrington-Manning asymptotic test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A non-inferiority margin of 6% was pre-specified.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Implant to 12 Months', 'description': 'The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) \\> 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were excluded if they withdrew, were lost to follow-up or have missing outcomes on original device.'}, {'type': 'SECONDARY', 'title': 'Number of HeartWare VAS Participants With Stroke/TIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HeartWare® VAS', 'description': 'HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.7363', 'groupIds': ['OG000'], 'paramType': 'Percent of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '19.2', 'ciLowerLimit': '15.6', 'ciUpperLimit': '23.3', 'estimateComment': 'Two-sided exact binomial confidence interval used', 'groupDescription': 'The first secondary endpoint is the percent of participants with stroke/TIA at 12 months on the originally implanted device. It will be compared to 17.7%, which is the lower bound of a pre-defined margin of superiority based on the Endurance clinical trial.', 'statisticalMethod': 'Exact Binomial Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Implant to 12 Months', 'description': 'The first secondary endpoint is the number of HeartWare VAS participants with stroke/TIA at 12 months on the originally implanted device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were excluded if they withdrew or were lost to follow up on the original device.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stroke-Free Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HeartWare® VAS', 'description': 'HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.'}, {'id': 'OG001', 'title': 'Control LVAD', 'description': 'Control LVAD: Any FDA-approved LVAD for destination therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '229', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-9.2', 'ciLowerLimit': '-17.2', 'ciUpperLimit': '-1.1', 'estimateComment': 'Difference = Control success rate - HeartWare® VAS success rate Two-sided 90% exact binomial confidence interval is used', 'statisticalMethod': 'Farrington-Manning asymptotic test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin on the difference in success proportions is 15%.'}, {'pValue': '0.0354', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Implant to 12 Months', 'description': 'Success is defined as alive on the originally implanted device, electively transplanted or explanted due to subject recovery and free from disabling stroke (Modified Rankin Scale \\>=4).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were excluded if they had no associated 24 week post-stroke Modified Rankin Scale value, or if the subject withdrew or was lost to follow-up on original device, and no other failure outcome occurred within 1 year post original implant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HeartWare® Ventricular Assist System (VAS)', 'description': 'HeartWare® Ventricular Assist System (VAS): The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.'}, {'id': 'FG001', 'title': 'Control Left Ventricular Assist Device (LVAD)', 'description': 'Control Left Ventricular Assist Device (LVAD): Any Food and Drug Administration (FDA)-approved LVAD for destination therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '308'}, {'groupId': 'FG001', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '304'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': "Subjects were considered enrolled upon signing informed consent. 19 enrolled subjects weren't randomized as they were considered screen failures. 10 subjects were randomized but didn't receive a device due to death (with 1 subject dying post anesthesia but prior to Left Ventricular Assist Device (LVAD) implant) or screen failure prior to implant."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '465', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HeartWare® VAS', 'description': 'HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.'}, {'id': 'BG001', 'title': 'Control LVAD', 'description': 'Control LVAD: Any FDA-approved LVAD for destination therapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.3', 'spread': '11.44', 'groupId': 'BG000'}, {'value': '64.2', 'spread': '11.14', 'groupId': 'BG001'}, {'value': '63.6', 'spread': '11.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '288', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '442', '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/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian/Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black/African American', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian/Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '339', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 494}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-01', 'studyFirstSubmitDate': '2013-10-17', 'resultsFirstSubmitDate': '2018-02-12', 'studyFirstSubmitQcDate': '2013-10-18', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-22', 'studyFirstPostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Neurologic Injury', 'timeFrame': 'Implant to 12 Months', 'description': 'The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) \\> 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability.'}], 'secondaryOutcomes': [{'measure': 'Number of HeartWare VAS Participants With Stroke/TIA', 'timeFrame': 'Implant to 12 Months', 'description': 'The first secondary endpoint is the number of HeartWare VAS participants with stroke/TIA at 12 months on the originally implanted device.'}, {'measure': 'Number of Participants With Stroke-Free Success', 'timeFrame': 'Implant to 12 Months', 'description': 'Success is defined as alive on the originally implanted device, electively transplanted or explanted due to subject recovery and free from disabling stroke (Modified Rankin Scale \\>=4).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '32740343', 'type': 'DERIVED', 'citation': 'Mahr C, McGee E Jr, Cheung A, Mokadam NA, Strueber M, Slaughter MS, Danter MR, Levy WC, Cheng RK, Beckman JA, May DM, Ismyrloglou E, Tsintzos SI, Silvestry SC. Cost-Effectiveness of Thoracotomy Approach for the Implantation of a Centrifugal Left Ventricular Assist Device. ASAIO J. 2020 Aug;66(8):855-861. doi: 10.1097/MAT.0000000000001209.'}, {'pmid': '32740129', 'type': 'DERIVED', 'citation': 'Silvestry SC, Mahr C, Slaughter MS, Levy WC, Cheng RK, May DM, Ismyrloglou E, Tsintzos SI, Tuttle E, Cook K, Birk E, Gomes A, Graham S, Cotts WG. Cost-Effectiveness of a Small Intrapericardial Centrifugal Left Ventricular Assist Device. ASAIO J. 2020 Aug;66(8):862-870. doi: 10.1097/MAT.0000000000001211.'}, {'pmid': '30007559', 'type': 'DERIVED', 'citation': 'Milano CA, Rogers JG, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Mokadam NA, Mahr C, Miller JS, Markham DW, Jeevanandam V, Uriel N, Aaronson KD, Vassiliades TA, Pagani FD; ENDURANCE Investigators. HVAD: The ENDURANCE Supplemental Trial. JACC Heart Fail. 2018 Sep;6(9):792-802. doi: 10.1016/j.jchf.2018.05.012. Epub 2018 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.', 'detailedDescription': 'The study will evaluate non-inferiority of neurologic injury incidence in a new cohort of subjects receiving improved blood pressure management to a control group (i.e., any FDA-approved LVAD for destination therapy). Secondary endpoints include: a comparison of stroke/TIA incidence to a reference observed in the original IDE clinical trial (HW004) that did not specify improved blood pressure management; and non-inferiority of stroke-free success on the originally implanted device to the control group. Subjects will be randomized to HeartWare® HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare® HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 60 months post-implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Must be ≥18 years of age at consent\n2. Body Surface Area (BSA) ≥ 1.2 m2\n3. Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following)a. On optimal medical management, including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or b. In Class III or Class IV heart failure for at least 14 days, and dependent on intra-aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days\n4. Left ventricular ejection fraction ≤ 25%\n5. LVAD implant is intended as destination therapy\n6. Must be able to receive either the HeartWare® HVAD or control LVAD\n7. Patient must agree to participate in and comply with an improved blood pressure management program, including maintenance of a patient diary.\n8. Female patients of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.\n9. The patient or legally authorized representative has signed the informed consent form\n\nExclusion Criteria:\n\n1. Body Mass Index (BMI) \\> 40\n2. Existence of any ongoing mechanical circulatory support (MCS) other than an intra-aortic balloon pump (IABP)\n3. Prior cardiac transplant.\n4. History of confirmed, untreated abdominal or thoracic aortic aneurysm \\> 5 cm.\n5. Cardiothoracic surgery within 30 days of randomization.\n6. Acute myocardial infarction within 14 days of implant as diagnosed by ST or T wave changes on the ECG, diagnostic biomarkers, ongoing pain and hemodynamic abnormalities as described (Figure 2) in the guidelines published in ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction ;.\n7. Patients eligible for cardiac transplantation\n8. On ventilator support for \\> 72 hours within the four days immediately prior to randomization and implant.\n9. Pulmonary embolus within three weeks of randomization as documented by computed tomography (CT) scan or nuclear scan.\n10. Symptomatic cerebrovascular disease, stroke within 180 days of randomization or \\> 80% stenosis of carotid or cranial vessels.\n11. Uncorrected moderate to severe aortic insufficiency. Correction may include repair or bioprosthesis at the time of implant.\n12. Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support or extracorporeal membrane oxygenation (ECMO) at the time of screening/randomization or right atrial pressure \\> 20 mmHg on multiple inotropes or right ventricular ejection fraction (RVEF) \\<15% with clinical signs of severe right heart failure (e.g. Lower extremity edema, ascites or pleural effusions refractory to treatment with diuretics and two inotropic drugs).\n13. Active, uncontrolled infection diagnosed by a combination of clinical symptoms and laboratory testing, including but not limited to, continued positive cultures, elevated temperature and white blood cell (WBC) count, hypotension, tachycardia, generalized malaise despite appropriate antibiotic, antiviral or antifungal treatment.\n14. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelet count \\< 75,000, INR \\> 2.0 or PTT \\> 2.5 times control in the absence of anticoagulation therapy).\n15. Intolerance to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.\n16. Serum creatinine \\> 3.0 mg/dL within 72 hours of randomization or requiring dialysis or ultrafiltration.\n17. Specific liver enzymes \\[AST (SGOT) and ALT (SGPT\\] \\> 3 times upper limit of normal within 72 hours of randomization.\n18. A total bilirubin \\> 3 mg/dl within 72 hours of randomization, or biopsy proven liver cirrhosis or portal hypertension.\n19. Pulmonary vascular resistance is demonstrated to be unresponsive to pharmacological manipulation and the PVR \\> 6 Wood units.\n20. Patients with a mechanical heart valve.\n21. Etiology of heart failure is due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy\n22. History of severe COPD or severe restrictive lung disease (e.g. FEV1 \\<50%)\n23. Participation in any other study involving investigational drugs or devices\n24. Severe illness, other than heart disease, which would limit survival to \\< 3 years\n25. Peripheral vascular disease with rest pain or ischemic ulcers of the extremities\n26. Pregnancy\n27. Patient unwilling or unable to comply with study requirements\n28. Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator"}, 'identificationModule': {'nctId': 'NCT01966458', 'acronym': 'DT2', 'briefTitle': 'A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure', 'orgStudyIdInfo': {'id': 'HW004-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HeartWare® VAS (HVAD)', 'description': 'Implant of HeartWare® Ventricular Assist System', 'interventionNames': ['Device: HeartWare® VAS (HVAD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control LVAD', 'description': 'Implant of FDA-approved LVAD approved for destination therapy', 'interventionNames': ['Device: Control LVAD']}], 'interventions': [{'name': 'HeartWare® VAS (HVAD)', 'type': 'DEVICE', 'description': 'The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.', 'armGroupLabels': ['HeartWare® VAS (HVAD)']}, {'name': 'Control LVAD', 'type': 'DEVICE', 'description': 'Any FDA-approved LVAD for destination therapy.', 'armGroupLabels': ['Control LVAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic (Arizona)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 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