Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-03 @ 7:53 PM
Study NCT ID:
NCT02497950
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2015-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HeartMate 3 ELEVATE™ Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'finn.gustafsson@regionh.dk', 'phone': '+4535459743', 'title': 'Prof. Finn Gustafsson', 'organization': 'Rigshospitalet Copenhagen, Denmark'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 years', 'eventGroups': [{'id': 'EG000', 'title': 'ELEVATE Patients', 'description': 'The ELEVATE study included 540 subjects of which: 463 pts received HM3 as primary implant and 19 pts received the HM3 as a replacement of another durable LVAD. These 2 groups ( 482 pts) consist the main study population, for which complete information has been collected. In addition, 58 patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)', 'otherNumAtRisk': 482, 'deathsNumAtRisk': 540, 'otherNumAffected': 277, 'seriousNumAtRisk': 482, 'deathsNumAffected': 209, 'seriousNumAffected': 407}], 'otherEvents': [{'term': 'Cardiac Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 69, 'numAffected': 53}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 90, 'numAffected': 59}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 262, 'numAffected': 166}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Fluid Collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Non Serious Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 826, 'numAffected': 277}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Arterial Non-CNS Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 112, 'numAffected': 79}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 281, 'numAffected': 155}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 552, 'numAffected': 258}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 86, 'numAffected': 73}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Fluid Collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 38, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 69, 'numAffected': 59}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 95, 'numAffected': 86}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 80, 'numAffected': 70}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 482, 'numEvents': 473, 'numAffected': 219}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Cohort', 'description': 'The ELEVATE Full Cohort includes 540 subjects of which:\n\n482 implanted patients who provided informed consent 58 implanted patients who had an outcome prior having the possibility to sign the Informed Consent. For those subject no patient data was collected, only duration of support and type of outcome'}], 'classes': [{'categories': [{'measurements': [{'value': '293', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 Years post-implant', 'description': 'Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ELEVATE Study included 540 subjects of which: 482 received HM3 and provided informed consent, while 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)'}, {'type': 'SECONDARY', 'title': 'EuroQoL-5D-5L (EQ-5D-5L) VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELEVATE Patients', 'description': 'Out of 540 enrolled patients, secondary outcomes were not collected for 58 subjects'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': '3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': '4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': '5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS', 'description': 'EuroQoL-5D-5L Visual Analog Score (VAS) measures self-rated health status/quality of life, with the patient indicating his/ger current status of health on a scale from 1 (extremely poor) to 100 (exceptionally good).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 540 enrolled patients, secondary outcome data were not collected for 58 patients'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELEVATE Patients Horts', 'description': 'Out of 540 enrolled patients, secondary outcomes were not collected for 58 patients'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '102.9', 'spread': '139.5', 'groupId': 'OG000'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '370.7', 'spread': '116.6', 'groupId': 'OG000'}]}]}, {'title': '2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '343.8', 'spread': '127.3', 'groupId': 'OG000'}]}]}, {'title': '3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '356.7', 'spread': '132.2', 'groupId': 'OG000'}]}]}, {'title': '4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '328.9', 'spread': '137.7', 'groupId': 'OG000'}]}]}, {'title': '5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '301.2', 'spread': '131.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 years after implant', 'description': "The Six Minute Walk Test (6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.", 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The test was collected only if performed as per center's Standard of Care."}, {'type': 'SECONDARY', 'title': 'New York Heart Association (NYHA) Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELEVATE Patients', 'description': 'Out of 540 enrolled patients, secondary outcomes were not collected for 58 patients'}], 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 5 years after implant', 'description': 'NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received HM3 as either a primary implant and patients who received the HM3 or a replacement of another durable LVAD'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELEVATE Patients', 'description': 'Out of 540 enrolled patients, secondary outcomes were not collected for 58 patients'}], 'classes': [{'title': 'Arterial Non-CNS Thromboembolism', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac Arrhythmias', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Hemolysis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Hepatic Dysfunction', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Major Bleeding', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}]}]}, {'title': 'Major Infection', 'categories': [{'measurements': [{'value': '258', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial Infarction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Neurologic Dysfunction', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}, {'title': 'Pericardial Fluid Collection', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Psychiatric Episode', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Renal Dysfunction', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Right Heart Failure', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Venous Thromboembolism', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Wound Dehiscence', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Other Adverse Event/Adverse Device Effect', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years post-implant', 'description': 'Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)'}, {'type': 'SECONDARY', 'title': 'Device Malfunctions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELEVATE Patients', 'description': 'Out of 540 enrolled patients, secondary outcomes were not collected for 58 patients'}], 'classes': [{'title': 'Thrombus: pump cover', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Thrombus: inflow cannula (ingested)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Thrombus: outflow graft', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Outflow graft bend relief disconnect', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Outflow graft twist', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Outflow graft kink', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Dreiveline communication fault', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Driveline damage - external', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Driveline issue', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Driveline disconnect causing pump stop', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Driveline bend relief damage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Modular cable outer jacket tear', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Controller issue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years post-implant', 'description': 'Number of device malfunctions reported', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)'}, {'type': 'SECONDARY', 'title': 'Reoperations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELEVATE Patients', 'description': 'Out of 540 enrolled patients, secondary outcomes were not collected for 58 patients'}], 'classes': [{'categories': [{'measurements': [{'value': '774', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years post-implant', 'description': 'Frequency and incidence of reoperations after initial implant surgery', 'unitOfMeasure': 'number of reoperation events', 'reportingStatus': 'POSTED', 'populationDescription': 'The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)'}, {'type': 'SECONDARY', 'title': 'Rehospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ELEVATE Patients', 'description': 'Out of 540 enrolled patients, secondary outcomes were not collected for 58 subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '1418', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years post-implant', 'description': 'Frequency and incidence of rehospitalizations after initial discharge from implant surgery', 'unitOfMeasure': 'number of rehospitalization events', 'reportingStatus': 'POSTED', 'populationDescription': 'The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Elevate Full Cohort', 'description': 'The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '540'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '332'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '209'}]}, {'type': 'Transplanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '85'}]}, {'type': 'Explanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Device Permanently Deactivated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Implanted/Exchanged to an LVAD other than HM3', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Center Did Not Participate in Long-Term FU', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Refused Consent to Long-Term FU', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'The ELEVATE study included 540 subjects of which: 482 implanted patients who provided informed consent, and 58 implanted patients had an outcome prior to having the possibility to sign the Informed Consent. For those, no patient data was collected, only duration of support and type of outcome (limited information available)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ELEVATE Consented and Implanted Patients', 'description': 'Patients who received HM3 and provided informed consent'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '11.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '429', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '372', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Kazakhstan', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '262', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'NYHA Class', 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Class IIIA', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Class IIIB', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '234', 'groupId': 'BG000'}]}]}, {'title': 'Not provided', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.\n\nClass IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.', 'unitOfMeasure': 'Participants'}, {'title': 'INTERMACS Profile', 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}]}]}, {'title': '5', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Not provided', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'INTERMACS Profiles describe the Heart Failure stage of the patients:\n\n1. Critical cardiogenic shock\n2. Progressive decline on inotropic support\n3. Stable but inotrope dependent\n4. Resting symptoms home on oral therapy\n5. Exertion intolerant\n6. Exertion limited\n7. Advanced NYHA Class III symptom', 'unitOfMeasure': 'Participants'}, {'title': 'Indication', 'classes': [{'title': 'Bridge to Transplant', 'categories': [{'measurements': [{'value': '320', 'groupId': 'BG000'}]}]}, {'title': 'Destination Therapy', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}, {'title': 'Other Indication', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The intended use of the device is either long-term (Destination Therapy), short term until a heart donor becomes available (bridge to transplant), or other.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Out of the 540 enrolled patients, baseline data were not collected for 58 subjects'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-20', 'size': 292536, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-10T06:19', 'hasProtocol': True}, {'date': '2019-06-20', 'size': 106396, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-02-10T06:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 540}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2015-07-03', 'resultsFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-28', 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Up to 5 Years post-implant', 'description': 'Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'EuroQoL-5D-5L (EQ-5D-5L) VAS', 'timeFrame': 'Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS', 'description': 'EuroQoL-5D-5L Visual Analog Score (VAS) measures self-rated health status/quality of life, with the patient indicating his/ger current status of health on a scale from 1 (extremely poor) to 100 (exceptionally good).'}, {'measure': 'Six Minute Walk Test (6MWT)', 'timeFrame': 'At 5 years after implant', 'description': "The Six Minute Walk Test (6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status."}, {'measure': 'New York Heart Association (NYHA) Classification', 'timeFrame': 'At 5 years after implant', 'description': 'NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 5 years post-implant', 'description': 'Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges)'}, {'measure': 'Device Malfunctions', 'timeFrame': 'Up to 5 years post-implant', 'description': 'Number of device malfunctions reported'}, {'measure': 'Reoperations', 'timeFrame': 'Up to 5 years post-implant', 'description': 'Frequency and incidence of reoperations after initial implant surgery'}, {'measure': 'Rehospitalizations', 'timeFrame': 'Up to 5 years post-implant', 'description': 'Frequency and incidence of rehospitalizations after initial discharge from implant surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HeartMate 3', 'LVAS', 'LVAD', 'Heart-assist devices', 'Thoratec Corporation'], 'conditions': ['Heart Failure', 'Cardiovascular Disease', 'Ventricular Dysfunction']}, 'referencesModule': {'references': [{'pmid': '33107561', 'type': 'DERIVED', 'citation': 'Zimpfer D, Gustafsson F, Potapov E, Pya Y, Schmitto J, Berchtold-Herz M, Morshuis M, Shaw SM, Saeed D, Lavee J, Heatley G, Gazzola C, Garbade J. Two-year outcome after implantation of a full magnetically levitated left ventricular assist device: results from the ELEVATE Registry. Eur Heart J. 2020 Oct 14;41(39):3801-3809. doi: 10.1093/eurheartj/ehaa639.'}, {'pmid': '30291831', 'type': 'DERIVED', 'citation': 'Garbade J, Gustafsson F, Shaw S, Lavee J, Saeed D, Pya Y, Krabatsch T, Schmitto JD, Morshuis M, Chuang J, Zimpfer D. Postmarket Experience With HeartMate 3 Left Ventricular Assist Device: 30-Day Outcomes From the ELEVATE Registry. Ann Thorac Surg. 2019 Jan;107(1):33-39. doi: 10.1016/j.athoracsur.2018.07.092. Epub 2018 Oct 3.'}, {'pmid': '30165521', 'type': 'DERIVED', 'citation': 'Gustafsson F, Shaw S, Lavee J, Saeed D, Pya Y, Krabatsch T, Schmitto J, Morshuis M, Chuang J, Damme L, Zimpfer D, Garbade J. Six-month outcomes after treatment of advanced heart failure with a full magnetically levitated continuous flow left ventricular assist device: report from the ELEVATE registry. Eur Heart J. 2018 Oct 1;39(37):3454-3460. doi: 10.1093/eurheartj/ehy513.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.', 'detailedDescription': 'The purpose of this post-market registry is to collect data and evaluate the real-world experience of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) in a post-approval setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that receive the HeartMate 3 LVAS in the post-approval setting', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n1. Patient consented to registry data collection\n2. Patient has met the HeartMate 3 commercially approved labeling indication and is implanted with the HM3.'}, 'identificationModule': {'nctId': 'NCT02497950', 'acronym': 'ELEVATE™', 'briefTitle': 'HeartMate 3 ELEVATE™ Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)', 'orgStudyIdInfo': {'id': 'HeartMate 3™ Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HeartMate 3', 'description': 'This registry will include all patients that receive the HM3 LVAS in the post-market setting', 'interventionNames': ['Device: HeartMate 3']}], 'interventions': [{'name': 'HeartMate 3', 'type': 'DEVICE', 'otherNames': ['HM3'], 'description': 'Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3', 'armGroupLabels': ['HeartMate 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AJH - Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '4', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institute for Clinical and Experimental Medicine (IKEM)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Universitatsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '97616', 'city': 'Bad Neustadt an der Saale', 'country': 'Germany', 'facility': 'Herz- und Gefäßklinik Bad Neustadt a d Saale', 'geoPoint': {'lat': 50.32174, 'lon': 10.20673}}, {'zip': '32545', 'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Herz-und Diabetes Zentrum NRW', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Medizinische Einrichtungen der Universitat Dusseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '79106', 'city': 'Freiberg', 'country': 'Germany', 'facility': 'Universitäts-Herzzentrum Freiburg', 'geoPoint': {'lat': 50.91089, 'lon': 13.33881}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '07740', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '04280', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzentrum Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'Otto-von-Guericke-Universitat Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitätsklinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '52621', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00152', 'city': 'Roma', 'country': 'Italy', 'facility': 'Az. Osp. San Camillo Forlanini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Ospedale Civile Maggiore di Verona Borgo Trento', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '010000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'National Research Center for Cardiac Surgery', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '3015', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC - Thoraxcenter', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '02-943', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Warsaw Institute of Cardiology', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '169609', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Heart Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Wythenshawe Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Finn Gustafsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Jens Garbade, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gesundheit Nord Klinikverbund Bremen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Thoratec Europe Ltd', 'class': 'INDUSTRY'}, {'name': 'Thoratec Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}