Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 7:09 PM
Study NCT ID:
NCT04069156
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2019-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The ARIES HeartMate 3 Pump IDE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nourdine.chakouri@abbott.com', 'phone': '(925) 989-5982', 'title': 'Nourdine Chakouri, PhD', 'organization': 'Abbott'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We excluded patients with early surgical complications or those that required mechanical support devices in addition to the implanted LVAD, or when investigators deemed aspirin therapy necessary.'}}, 'adverseEventsModule': {'timeFrame': 'All adverse events occurring through study completion (median follow up of 14 months) were collected.', 'description': "An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.', 'otherNumAtRisk': 296, 'deathsNumAtRisk': 296, 'otherNumAffected': 200, 'seriousNumAtRisk': 296, 'deathsNumAffected': 21, 'seriousNumAffected': 208}, {'id': 'EG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).', 'otherNumAtRisk': 293, 'deathsNumAtRisk': 293, 'otherNumAffected': 181, 'seriousNumAtRisk': 293, 'deathsNumAffected': 22, 'seriousNumAffected': 223}], 'otherEvents': [{'term': 'Major Infection', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 129, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 118, 'numAffected': 92}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Cardiac Arrhythmia', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Hepatic Dysfunction', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Venous Thromboembolism', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Bleeding', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Renal Dysfunction', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Blood And Lymphatic System Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Cardiac Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 52, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 33, 'numAffected': 23}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Eye Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Gastrointestinal Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'General Disorders And Administration Site Conditions', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 43, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Hepatobiliary Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Infections And Infestations', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Injury, Poisoning And Procedural Complications', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 31, 'numAffected': 24}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Investigations', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 51, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 54, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Metabolism And Nutrition Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 61, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Musculoskeletal And Connective Tissue Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Nervous System Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Psychiatric Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Renal And Urinary Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 29, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Reproductive System And Breast Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Respiratory, Thoracic And Mediastinal Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 31, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 31, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Skin And Subcutaneous Tissue Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Vascular Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 44, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 49, 'numAffected': 39}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}], 'seriousEvents': [{'term': 'Bleeding', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 92, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 138, 'numAffected': 100}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Hemolysis', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Cardiac Arrhythmia', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 59, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 73, 'numAffected': 41}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Right Heart Failure', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Hepatic Dysfunction', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Major Infection', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 201, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 197, 'numAffected': 116}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Neurologic Dysfunction', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 29, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Respiratory Failure', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Renal Dysfunction', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Venous Thromboembolism', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Hypertension', 'notes': 'Site reported event terms were used for protocol defined adverse events.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Blood And Lymphatic System Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Cardiac Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 64, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 51, 'numAffected': 35}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Ear And Labyrinth Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Endocrine Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Eye Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Gastrointestinal Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 17, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'General Disorders And Administration Site Conditions', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 34, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Hepatobiliary Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Immune System Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Infections And Infestations', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Injury, Poisoning And Procedural Complications', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Investigations', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Metabolism And Nutrition Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 40, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 44, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Musculoskeletal And Connective Tissue Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Nervous System Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 34, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Pregnancy, Puerperium And Perinatal Conditions', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Psychiatric Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Renal And Urinary Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Study Protocol'}, {'term': 'Respiratory, Thoracic And Mediastinal Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 35, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 31, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Skin And Subcutaneous Tissue Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Social Circumstances', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Surgical And Medical Procedures', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}, {'term': 'Vascular Disorders', 'notes': 'Other events reported by MedDRA system organ classification.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 296, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA system'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Principal Analysis Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Principal Analysis Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '6', 'ciLowerLimit': '-1.6', 'statisticalMethod': 'Farrington-Manning risk difference', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The primary end point assessing non-inferiority of placebo was considered met if the lower boundary of the one-sided 97.5% confidence limit of the difference in the composite success rate between treatment arms (placebo minus aspirin) was greater than the non-inferiority margin (-10%) by the Farrington-Manning test at 12-months in the principal analysis population.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary end point was analyzed in the principal analysis population, which excluded patients with events occurring within 14 days after LVAD implantation to avoid counting surgical complications not attributed to the treatment.'}, {'type': 'SECONDARY', 'title': 'Rates of Non-surgical Major Hemorrhagic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'title': 'All Non-surgical Major Hemorrhagic events', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '40.7', 'groupId': 'OG001'}]}]}, {'title': 'Bleeding', 'categories': [{'measurements': [{'value': '25.93', 'groupId': 'OG000'}, {'value': '39.53', 'groupId': 'OG001'}]}]}, {'title': 'Hemorrhagic Stroke', 'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000'}, {'value': '0.85', 'groupId': 'OG001'}]}]}, {'title': 'Ischemic Stroke with Hemorrhagic Conversion', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'The rate of non-surgical hemorrhagic events were compared between the two arms of the study. Non-surgical Major Hemorrhagic events: Hemorrhagic event rate per patient year was calculated by dividing all non-surgical bleeding events and hemorrhagic stroke events by the cumulative years of study exposure.', 'unitOfMeasure': 'Event Per 100 Patient-Year', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention to Treat Population (mITT)'}, {'type': 'SECONDARY', 'title': 'Rates of Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'title': 'All Bleeding Events', 'categories': [{'measurements': [{'value': '25.92', 'groupId': 'OG000'}, {'value': '39.53', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Bleeding', 'categories': [{'measurements': [{'value': '8.46', 'groupId': 'OG000'}, {'value': '13.65', 'groupId': 'OG001'}]}]}, {'title': 'Severe Bleeding', 'categories': [{'measurements': [{'value': '17.47', 'groupId': 'OG000'}, {'value': '25.88', 'groupId': 'OG001'}]}]}, {'title': 'GI Bleeding', 'categories': [{'measurements': [{'value': '13.10', 'groupId': 'OG000'}, {'value': '21.61', 'groupId': 'OG001'}]}]}, {'title': 'Fatal Bleeding', 'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000'}, {'value': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support).', 'unitOfMeasure': 'Event Per 100 Patient-Year', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention to Treat Population (mITT)'}, {'type': 'SECONDARY', 'title': 'Rates of Non-surgical Major Thrombotic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'title': 'All Major Thrombotic events', 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000'}, {'value': '2.84', 'groupId': 'OG001'}]}]}, {'title': 'Ischemic Stroke without Hemorrhagic Conversion', 'categories': [{'measurements': [{'value': '1.64', 'groupId': 'OG000'}, {'value': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Device Thrombosis', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Arterial Peripheral Thromboembolism', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'The rates of non-surgical major thrombotic events was compared between the two arms of the study. The thrombotic event rate per patient year was calculated by dividing the number of non-surgical ischemic strokes, pump thrombosis and arterial peripheral thromboembolic events by the cumulative years of study exposure', 'unitOfMeasure': 'Event Per 100 Patient-Year', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention to Treat Population (mITT)'}, {'type': 'SECONDARY', 'title': 'Rates of Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'title': 'All Stroke', 'categories': [{'measurements': [{'value': '1.91', 'groupId': 'OG000'}, {'value': '3.70', 'groupId': 'OG001'}]}]}, {'title': 'Debilitating Stroke (MRS>3)', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000'}, {'value': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Non-Debilitating Stroke (MRS<=3)', 'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000'}, {'value': '3.13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'The stroke rate was calculated based on the number of strokes experienced by subjects, 14 days or more after device implant, and while on their treatment assignment, divided by the cumulative duration of study exposure (years of support).', 'unitOfMeasure': 'Event Per 100 Patient-Year', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention to Treat Population (mITT)'}, {'type': 'SECONDARY', 'title': 'Survival Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '89.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'The overall survival rate was analyzed using a Kaplan-Meier analysis and the treatment groups were compared using log-rank test. Survival was calculated starting at 14 days post implant.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention to Treat Population (mITT)'}, {'type': 'SECONDARY', 'title': 'Risk of Non-Surgical Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '42.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 Months', 'description': 'Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention to Treat Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Rehospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'title': 'Hemocompatibility Related', 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000'}, {'value': '0.28', 'groupId': 'OG001'}]}]}, {'title': 'Major Infection', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000'}, {'value': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000'}, {'value': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular Related', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000'}, {'value': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Non-cardiovascular organ dysfunction', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}, {'value': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Neurologic dysfunction (excluding stroke, TIA)', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000'}, {'value': '0.42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'This study assessed changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen.', 'unitOfMeasure': 'Event Per 100 Patient-Year', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention to Treat Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '546,947', 'groupId': 'OG000'}, {'value': '927,040', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included.', 'unitOfMeasure': 'USD', 'reportingStatus': 'POSTED', 'populationDescription': 'Only US subjects were included in this analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Economic Cost Implications - Average Cost Per Bleeding Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '13,674', 'groupId': 'OG000'}, {'value': '13,836', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'These values were derived by dividing the total estimated cost for bleeding events by the number of events to determine the average cost per bleeding event. Consequently, a measure of dispersion is not available for these outcomes.', 'unitOfMeasure': 'USD', 'reportingStatus': 'POSTED', 'populationDescription': 'Only US subjects were included in this analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Economic Cost Implications - Average Cost Per Study Patient Over the First-year Post-implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '2,214', 'groupId': 'OG000'}, {'value': '3,799', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'These values were derived by dividing the total estimated cost for bleeding events by the number of patients to obtain the average cost per study patient. Consequently, a measure of dispersion is not available for these outcomes.', 'unitOfMeasure': 'USD', 'reportingStatus': 'POSTED', 'populationDescription': 'Only US subjects were included in this analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Economic Cost Implications - Cost of Bleeding Hospitalization for 1000 LVAD Implants Over the First-year Post-implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'OG001', 'title': 'Aspirin Arm (Modified Intent-to-treat Population)', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '2,214,362', 'groupId': 'OG000'}, {'value': '3,799,344', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included.', 'unitOfMeasure': 'USD/1000 implants/1 year', 'reportingStatus': 'POSTED', 'populationDescription': 'Only US subjects were included in this analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Arm', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'FG001', 'title': 'Aspirin Arm', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}], 'periods': [{'title': 'Modified Intent-to-Treat (mITT)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '18 patients experienced surgical events and outcomes required cessation of treatment within 14 days.', 'groupId': 'FG000', 'numSubjects': '314'}, {'comment': '21 patients experienced surgical events and outcomes required cessation of treatment within 14 days.', 'groupId': 'FG001', 'numSubjects': '314'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '293'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Transitioned to open label', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}, {'title': 'Principal Analysis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '293'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '273'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Withdrawn without primary end point event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}], 'recruitmentDetails': 'The study enrolled and randomized 628 subjects at 51 sites. Enrollment took place between July 2020 and September 2022, with the last subject follow up concluding in August 2023.', 'preAssignmentDetails': 'The intent to treat (ITT) population consisted of all subjects randomized including follow up beyond transition to open label (n=314 in each arm).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '589', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Arm', 'description': 'Patients randomized to the placebo arm were given placebo medication.'}, {'id': 'BG001', 'title': 'Aspirin Arm', 'description': 'Patients randomized to the aspirin arm were given aspirin medication (100mg/day).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '57.1', 'spread': '13.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '456', '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': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heart Failure Etiology', 'classes': [{'categories': [{'title': 'Ischemic Cardiomyopathy', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}, {'title': 'Idiopathic Cardiomyopathy', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Dilated Cardiomyopathy', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intended Use', 'classes': [{'categories': [{'title': 'Bridge to Transplantation', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': 'Bridge to Candidacy for Transplantation', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Destination Therapy', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}, {'title': 'Bridge to Recovery', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'INTERMACS Profile', 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': '5', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '6', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '7', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'INTERMACS profiles describe the clinical profile of advanced heart failure patients who may be candidates for mechanical circulatory support. There are 7 profiles ranging from Profile 1 (most sick) to Profile 7 (least sick). Profile 1 indicates critical cardiogenic shock. Profile 2 indicates progressive decline. Profile 3 indicates stable but inotrope dependent. Profile 4 indicates resting symptoms. Profile 5 indicates exertion intolerant. Profile 6 indicates exertion limited. Profile 7 indicates advanced NYHA Class 3 (clinically stable with a reasonable level of comfortable activity).', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association (NYHA) Class', 'classes': [{'categories': [{'title': 'Class II', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Class IIIA', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Class IIIB', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Class IV', 'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '450', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The NYHA functional classification consists of four categories, with Class IV being the worse class.\n\n* Class I: No symptoms or limitation in ordinary physical activity\n* Class II: Mild symptoms and slight limitation during ordinary activity\n* Class IIIA or B: NYHA class IIIA patients experience no dyspnea at rest, while NYHA class IIIB patients experience recent dyspnea at rest. Both patient classes have marked limitations in physical activity, even with less than ordinary activity.\n* Class IV: Severe limitations, experiences symptoms even while at rest', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'categories': [{'title': 'North America', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Modified Intention to Treat Population (mITT) included all randomized subjects with the following exception:\n\n1. Subjects who experienced a surgical adverse event, defined as ≤14 days post-implant, requiring investigator mandated antiplatelet therapy;\n2. Subjects who expired, are transplanted, or withdrawn within 14 days of implant.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-13', 'size': 2538049, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-08T20:25', 'hasProtocol': True}, {'date': '2023-08-07', 'size': 497969, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-08T20:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigator, site, patient, CEC, and core lab are blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded, randomized 1:1, active arm versus placebo arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 628}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2019-08-21', 'resultsFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-26', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of Rehospitalization', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'This study assessed changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen.'}, {'measure': 'Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis)', 'timeFrame': '12 Months', 'description': 'Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included.'}, {'measure': 'Economic Cost Implications - Average Cost Per Bleeding Event', 'timeFrame': '12 Months', 'description': 'These values were derived by dividing the total estimated cost for bleeding events by the number of events to determine the average cost per bleeding event. Consequently, a measure of dispersion is not available for these outcomes.'}, {'measure': 'Economic Cost Implications - Average Cost Per Study Patient Over the First-year Post-implant', 'timeFrame': '12 Months', 'description': 'These values were derived by dividing the total estimated cost for bleeding events by the number of patients to obtain the average cost per study patient. Consequently, a measure of dispersion is not available for these outcomes.'}, {'measure': 'Economic Cost Implications - Cost of Bleeding Hospitalization for 1000 LVAD Implants Over the First-year Post-implant', 'timeFrame': '12 Months', 'description': 'Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included.'}], 'primaryOutcomes': [{'measure': 'Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events', 'timeFrame': '12 Months', 'description': 'The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.'}], 'secondaryOutcomes': [{'measure': 'Rates of Non-surgical Major Hemorrhagic Events', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'The rate of non-surgical hemorrhagic events were compared between the two arms of the study. Non-surgical Major Hemorrhagic events: Hemorrhagic event rate per patient year was calculated by dividing all non-surgical bleeding events and hemorrhagic stroke events by the cumulative years of study exposure.'}, {'measure': 'Rates of Bleeding Events', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support).'}, {'measure': 'Rates of Non-surgical Major Thrombotic Events', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'The rates of non-surgical major thrombotic events was compared between the two arms of the study. The thrombotic event rate per patient year was calculated by dividing the number of non-surgical ischemic strokes, pump thrombosis and arterial peripheral thromboembolic events by the cumulative years of study exposure'}, {'measure': 'Rates of Stroke', 'timeFrame': 'Through Study Completion with a Median Follow up of 14 Months', 'description': 'The stroke rate was calculated based on the number of strokes experienced by subjects, 14 days or more after device implant, and while on their treatment assignment, divided by the cumulative duration of study exposure (years of support).'}, {'measure': 'Survival Rates', 'timeFrame': '24 Months', 'description': 'The overall survival rate was analyzed using a Kaplan-Meier analysis and the treatment groups were compared using log-rank test. Survival was calculated starting at 14 days post implant.'}, {'measure': 'Risk of Non-Surgical Bleeding Events', 'timeFrame': '24 Months', 'description': 'Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['heart failure', 'ventricular assist device', 'LVAD', 'aspirin'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '37950897', 'type': 'BACKGROUND', 'citation': 'Mehra MR, Netuka I, Uriel N, Katz JN, Pagani FD, Jorde UP, Gustafsson F, Connors JM, Ivak P, Cowger J, Ransom J, Bansal A, Takeda K, Agarwal R, Byku M, Givertz MM, Bitar A, Hall S, Zimpfer D, Vega JD, Kanwar MK, Saeed O, Goldstein DJ, Cogswell R, Sheikh FH, Danter M, Pya Y, Phancao A, Henderson J, Crandall DL, Sundareswaran K, Soltesz E, Estep JD; ARIES-HM3 Investigators. Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2171-2181. doi: 10.1001/jama.2023.23204.'}, {'pmid': '39774588', 'type': 'BACKGROUND', 'citation': 'Gustafsson F, Uriel N, Netuka I, Katz JN, Pagani FD, Connors JM, Jorde UP, Zimpfer D, Pya Y, Conway J, Anyanwu A, Scandroglio AM, Sulemanjee N, Atluri P, Keebler M, Selzman CH, Alexis JD, Hayward C, Henderson J, Dirckx N, Gazzola C, Mehra MR; ARIES Investigators. Aspirin and Hemocompatibility After LVAD Implantation in Patients With Atherosclerotic Vascular Disease: A Secondary Analysis From the ARIES-HM3 Randomized Clinical Trial. JAMA Cardiol. 2025 Mar 1;10(3):235-242. doi: 10.1001/jamacardio.2024.4849.'}, {'pmid': '34142415', 'type': 'BACKGROUND', 'citation': 'Mehra MR, Crandall DL, Gustafsson F, Jorde UP, Katz JN, Netuka I, Uriel N, Connors JM, Sood P, Heatley G, Pagani FD. Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo-controlled, non-inferiority ARIES HM3 trial. Eur J Heart Fail. 2021 Jul;23(7):1226-1237. doi: 10.1002/ejhf.2275. Epub 2021 Jul 1.'}, {'pmid': '41258850', 'type': 'DERIVED', 'citation': "Katz JN, Connors JM, Pagani FD, Jorde UP, Gustafsson F, Uriel N, Netuka I, Byku M, Anyanwu A, Keebler M, Nathan S, Selzman CH, Alexis JD, Sulemanjee N, Atluri P, D'Allesandro D, Porter S, Lee FS, Mehra MR; ARIES Investigators. Hemocompatibility Outcomes With Pharmacological Therapy Following LVAD Implantation: Insights From the ARIES-HM3 Trial. JACC Heart Fail. 2025 Nov 17:102769. doi: 10.1016/j.jchf.2025.102769. Online ahead of print."}, {'pmid': '40208135', 'type': 'DERIVED', 'citation': 'Pagani FD, Netuka I, Jorde UP, Katz JN, Gustafsson F, Connors JM, Uriel N, Soltesz EG, Ivak P, Bansal A, Bitar A, Vega JD, Goldstein D, Danter M, Pya Y, Ravichandran A, Conway J, Adler ED, Chung ES, Grinstein J, Dirckx N, Iravani B, Mehra MR. Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy. JACC Heart Fail. 2025 Jul;13(7):102411. doi: 10.1016/j.jchf.2025.01.017. Epub 2025 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo', 'detailedDescription': 'This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.\n2. Subject will receive the HeartMate 3 as their first durable VAD.\n3. Subject must provide written informed consent prior to any clinical investigation related procedure.\n4. In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.\n\nExclusion Criteria:\n\n1. Post-implant additional temporary or permanent mechanical circulatory support (MCS).\n2. Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).\n3. Patients who are nil per os (NPO) post-implant through day 7.\n4. Subjects with a known allergy to acetylsalicylic acid (aspirin).\n5. Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.\n6. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results."}, 'identificationModule': {'nctId': 'NCT04069156', 'briefTitle': 'The ARIES HeartMate 3 Pump IDE Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study', 'orgStudyIdInfo': {'id': 'ABT-CIP-10305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'LVAD Patients on the placebo arm will be given placebo medication', 'interventionNames': ['Device: LVAD Implant', 'Drug: Placebo oral tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Arm', 'description': 'LVAD Patients on the active arm will be given 100mg Aspirin', 'interventionNames': ['Device: LVAD Implant', 'Drug: Aspirin 100mg']}], 'interventions': [{'name': 'LVAD Implant', 'type': 'DEVICE', 'description': 'Subjects will undergo Heartmate 3 LVAD implant prior to randomization', 'armGroupLabels': ['Active Arm', 'Placebo Arm']}, {'name': 'Aspirin 100mg', 'type': 'DRUG', 'description': 'Subjects will be randomized to either Placebo or Aspirin post implant.', 'armGroupLabels': ['Active Arm']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Subjects will be randomized to either Placebo or Aspirin post implant', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Baptist Health Medical Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center - Van Ness Campus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Transplant Institute - Jackson Memorial', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Christ Medical Center', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '46240', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center Fairview', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York-Presbyterian/Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center - Moses Division', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Integris Baptist Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Heart & Vascular Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital - ASRI', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aurora Medical Group', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New', 'country': 'Australia', 'facility': "St. Vincent's Hospital, Sydney", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'AKH - Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '140 24', 'city': 'Prague', 'state': 'Central Bohemia', 'country': 'Czechia', 'facility': 'IKEM Prague'}, {'zip': '33600', 'city': 'Pessac', 'country': 'France', 'facility': 'Hopital Haut Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '10000', 'city': 'Astana', 'country': 'Kazakhstan', 'facility': 'National Research Center for Cardiac Surgery', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': 'B15 2GW', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}