Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT02389894
Status:
COMPLETED
Last Update Posted:
2019-04-29
First Post:
2015-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neuroprotection in Patients Undergoing Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D058226', 'term': 'Plaque, Atherosclerotic'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'annetine.gelijns@mssm.edu', 'phone': '212-659-9568', 'title': 'Annetine C. Gelijns, PhD', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU).", 'otherNumAtRisk': 133, 'deathsNumAtRisk': 133, 'otherNumAffected': 45, 'seriousNumAtRisk': 133, 'deathsNumAffected': 4, 'seriousNumAffected': 72}, {'id': 'EG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU).", 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 47, 'seriousNumAtRisk': 118, 'deathsNumAffected': 5, 'seriousNumAffected': 53}, {'id': 'EG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.", 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 43, 'seriousNumAtRisk': 132, 'deathsNumAffected': 3, 'seriousNumAffected': 54}], 'otherEvents': [{'term': 'Acute Kidney Injury - Stage 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Infection - Localized Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute Kidney Injury - Stage 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury - Stage 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury - Stage 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding - Transfusion > 5 units RBC <24 hours following surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding - Re-operation for hemorrhage or tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmias - Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 43, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Fluid Collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic Dysfunction (Liver injury and Impaired Liver function)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Infection - Localized Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Infection - Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major Infection - Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction - Non-Procedure Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction - Peri-CABG', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological Dysfunction- Transient Ischemic Attack - TIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological Dysfunction- Ischemic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological Dysfunction- Toxic Metabolic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological Dysfunction- Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological Dysfunction- Other Neurological Dysfunction*', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Events (Renal Failure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous Thromboembolism Event - Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous Thromboembolism Event - Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous Thromboembolism Event - Other*', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adrenal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic Valve Re-operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disseminated Intravascular Coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia with PEG tube placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intra abdominal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthostatic Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-pericardiotomy Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Repair of Aorta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe TR requiring TV replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small bowel obstruction/ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '82.5'}, {'value': '68.0', 'groupId': 'OG001', 'lowerLimit': '59.1', 'upperLimit': '76.8'}, {'value': '67.6', 'groupId': 'OG002', 'lowerLimit': '58.8', 'upperLimit': '76.4'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '17.9', 'estimateComment': 'The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Embol-x minus control', 'groupDescription': 'A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.'}, {'pValue': '0.84', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '13.8', 'pValueComment': 'The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.', 'estimateComment': 'The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Cardiogard minus control.', 'groupDescription': 'A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 10 days post procedure', 'description': 'freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting \\> 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '20.5', 'estimateComment': 'The absolute difference was computed as Embol-x minus control', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.61', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-13.5', 'ciUpperLimit': '7.9', 'estimateComment': 'The absolute difference was computed as Cardiogard minus control', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 30 days', 'description': 'The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Three patients withdrew prior to day 30 and are not included in the denominators'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Clinically Apparent Stroke at 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 7 days', 'description': 'The number of patients who experience a clinically apparent stroke by 7 days post-op', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two patients withdrew prior to day 7'}, {'type': 'SECONDARY', 'title': 'Presence of Radiographic Infarcts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 10 days', 'description': 'The proportion of patients with radiographic infarcts on day 7 (+/-3 days) MRI. Presences of radiographic infarcts were measured using diffusion-weighted 1.5 or 3T MRI scanners', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Denominator includes all patients with day 7 MRI'}, {'type': 'SECONDARY', 'title': 'Total Infarct Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '322'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '151'}, {'value': '35', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '168'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7', 'description': 'Total infarct volume measured on day 7 dwMRI.', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all those with dwMRI at 7 days'}, {'type': 'SECONDARY', 'title': 'Decline in Overall Neurocognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the verbal memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the visual memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decline in Neurocognitive Function in the Executive Function Domain at 90 Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the executive function domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the visuospatial/constructional praxis domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the Auditory-Verbal Simple attention domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the Visuomotor/Information Processing Speed domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Modified Rankin Scale >2 at 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.\n\n1. \\- No significant disability. Able to carry out all usual activities, despite some symptoms.\n2. \\- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n3. \\- Moderate disability. Requires some help, but able to walk unassisted.\n4. \\- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n5. \\- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.\n6. \\- Dead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Barthel Index <= 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'An overall score has full range from 0 to 100, with higher scores indicating greater independence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality by 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 90 days', 'description': 'Incidence of all-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay for Index Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '6.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 90 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001'}, {'value': '7.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 90 days', 'description': 'Rate of hospital readmissions', 'unitOfMeasure': 'rate per 100-patient-months', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Physical Health Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '44.2', 'spread': '9.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 90 days', 'description': 'Quality of Life - Physical Health Composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life - Mental Health Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '55.4', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '54.8', 'spread': '8.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at 90 days', 'description': 'Quality of life - Mental health composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Emboli Captured', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'OG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'OG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 1', 'description': 'Assessed by the presence of any debris captured in filter of embolic protection device', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Emboli are not captured by the standard cannula and therefore no data are available for this group in this outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'FG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'FG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '383', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Embol-X Embolic Protection Device', 'description': "The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.\n\nEmbol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU)."}, {'id': 'BG001', 'title': 'CardioGard Cannula', 'description': "The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.\n\nCardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU)."}, {'id': 'BG002', 'title': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '74.6', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '73.6', 'spread': '6.7', 'groupId': 'BG002'}, {'value': '73.9', 'spread': '6.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '147', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '236', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '358', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '352', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '326', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2015-03-10', 'resultsFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-26', 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction', 'timeFrame': 'up to 10 days post procedure', 'description': 'freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting \\> 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury', 'timeFrame': 'up to 30 days', 'description': 'The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.'}, {'measure': 'Number of Patients With Clinically Apparent Stroke at 7 Days', 'timeFrame': 'at 7 days', 'description': 'The number of patients who experience a clinically apparent stroke by 7 days post-op'}, {'measure': 'Presence of Radiographic Infarcts', 'timeFrame': 'up to 10 days', 'description': 'The proportion of patients with radiographic infarcts on day 7 (+/-3 days) MRI. Presences of radiographic infarcts were measured using diffusion-weighted 1.5 or 3T MRI scanners'}, {'measure': 'Total Infarct Volume', 'timeFrame': 'Day 7', 'description': 'Total infarct volume measured on day 7 dwMRI.'}, {'measure': 'Decline in Overall Neurocognition', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.'}, {'measure': 'Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the verbal memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.'}, {'measure': 'Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the visual memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.'}, {'measure': 'Decline in Neurocognitive Function in the Executive Function Domain at 90 Day', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the executive function domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.'}, {'measure': 'Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the visuospatial/constructional praxis domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.'}, {'measure': 'Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the Auditory-Verbal Simple attention domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.'}, {'measure': 'Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days', 'timeFrame': 'baseline and 90 days', 'description': 'Decline in neurocognitive function in the Visuomotor/Information Processing Speed domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.'}, {'measure': 'Modified Rankin Scale >2 at 90 Days', 'timeFrame': '90 days', 'description': 'The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.\n\n1. \\- No significant disability. Able to carry out all usual activities, despite some symptoms.\n2. \\- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n3. \\- Moderate disability. Requires some help, but able to walk unassisted.\n4. \\- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n5. \\- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.\n6. \\- Dead.'}, {'measure': 'Barthel Index <= 80', 'timeFrame': '90 days', 'description': 'An overall score has full range from 0 to 100, with higher scores indicating greater independence.'}, {'measure': 'Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days', 'timeFrame': '7 days'}, {'measure': 'Mortality by 90 Days', 'timeFrame': 'up to 90 days', 'description': 'Incidence of all-cause mortality'}, {'measure': 'Length of Stay for Index Hospitalization', 'timeFrame': 'up to 90 days'}, {'measure': 'Hospital Readmissions', 'timeFrame': 'up to 90 days', 'description': 'Rate of hospital readmissions'}, {'measure': 'Quality of Life - Physical Health Composite', 'timeFrame': 'at 90 days', 'description': 'Quality of Life - Physical Health Composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.'}, {'measure': 'Quality of Life - Mental Health Composite', 'timeFrame': 'at 90 days', 'description': 'Quality of life - Mental health composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.'}, {'measure': 'Number of Participants With Emboli Captured', 'timeFrame': 'day 1', 'description': 'Assessed by the presence of any debris captured in filter of embolic protection device'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Embolic Protection Device', 'Stroke', 'Brain Infarction', 'atheroma', 'Aortic Valve Replacement'], 'conditions': ['Aortic Stenosis', 'Brain Infarction', 'Cerebrovascular Accident', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '35483981', 'type': 'DERIVED', 'citation': "Messe SR, Overbey JR, Thourani VH, Moskowitz AJ, Gelijns AC, Groh MA, Mack MJ, Ailawadi G, Furie KL, Southerland AM, James ML, Moy CS, Gupta L, Voisine P, Perrault LP, Bowdish ME, Gillinov AM, O'Gara PT, Ouzounian M, Whitson BA, Mullen JC, Miller MA, Gammie JS, Pan S, Erus G, Browndyke JN; Cardiothoracic Surgical Trials Network (CTSN) Investigators. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement. J Thorac Cardiovasc Surg. 2024 Feb;167(2):624-633.e4. doi: 10.1016/j.jtcvs.2022.01.053. Epub 2022 Mar 18."}, {'pmid': '30007783', 'type': 'DERIVED', 'citation': 'Crestanello JA. "Not in my brain": The use of embolic protection devices to prevent brain embolization during cardiovascular procedures. J Thorac Cardiovasc Surg. 2018 Dec;156(6):e205-e206. doi: 10.1016/j.jtcvs.2018.05.114. Epub 2018 Jun 23. No abstract available.'}, {'pmid': '28787505', 'type': 'DERIVED', 'citation': "Mack MJ, Acker MA, Gelijns AC, Overbey JR, Parides MK, Browndyke JN, Groh MA, Moskowitz AJ, Jeffries NO, Ailawadi G, Thourani VH, Moquete EG, Iribarne A, Voisine P, Perrault LP, Bowdish ME, Bilello M, Davatzikos C, Mangusan RF, Winkle RA, Smith PK, Michler RE, Miller MA, O'Sullivan KL, Taddei-Peters WC, Rose EA, Weisel RD, Furie KL, Bagiella E, Moy CS, O'Gara PT, Messe SR; Cardiothoracic Surgical Trials Network (CTSN). Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):536-547. doi: 10.1001/jama.2017.9479."}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).', 'detailedDescription': 'This is a multicenter randomized trial in which patients diagnosed with calcific aortic stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life Science filter and cannula or the filter as a stand alone with any cannula or 2) to the treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years\n* Planned and scheduled surgical aortic valve replacement via a full or minimal-access sternotomy (using central aortic perfusion cannulae) for calcific aortic stenosis with a legally marketed valve\n* No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization\n* Ability to provide informed consent and comply with the protocol\n\nExclusion Criteria:\n\n* Contraindication to legally marketed embolic protection devices (e.g. aneurysm of the ascending aorta, aortic trauma, porcelain aorta, known sensitivity to heparin)\n* History of clinical stroke within 3 months prior to randomization\n* Cardiac catheterization within 3 days of the planned aortic valve replacement\n* Cerebral and or aortic arch arteriography or interventions within 3 days of the planned aortic valve replacement\n* Active endocarditis at time of randomization\n* Anticipated inability to tolerate or contraindication for MRI (e.g., known intolerance of MRI, permanent pacemaker at baseline or expected implantation of a permanent pacemaker)\n* Any other concomitant aortic procedure such as root replacement\n* Concomitant surgical procedures other than CABG, mitral annuloplasty, left atrial appendage (LAA) excision or exclusion, atrial septal defect (ASD) closure or patent foramen ovale (PFO) closure\n* Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization\n* Concurrent participation in an interventional (drug or device) trial'}, 'identificationModule': {'nctId': 'NCT02389894', 'briefTitle': 'Neuroprotection in Patients Undergoing Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Neuroprotection In Patients Undergoing Aortic Valve Replacement', 'orgStudyIdInfo': {'id': 'GCO 08-1078-0009'}, 'secondaryIdInfos': [{'id': '2U01HL088942-07', 'link': 'https://reporter.nih.gov/quickSearch/2U01HL088942-07', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Embol-X Embolic Protection Device', 'description': 'The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.', 'interventionNames': ['Device: Embol-X Embolic Protection Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CardioGard Cannula', 'description': 'The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.', 'interventionNames': ['Device: CardioGard Cannula']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Cannula', 'description': "Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing."}], 'interventions': [{'name': 'Embol-X Embolic Protection Device', 'type': 'DEVICE', 'otherNames': ['Edwards Embol-X embolic protection device'], 'description': "per the manufacturer's instructions for use (IFU).", 'armGroupLabels': ['Embol-X Embolic Protection Device']}, {'name': 'CardioGard Cannula', 'type': 'DEVICE', 'otherNames': ['CardioGard Emboli Protection Cannula'], 'description': "CardioGard Cannula, per the manufacturer's instructions for use (IFU).", 'armGroupLabels': ['CardioGard Cannula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'NIH Heart Center at Suburban Hospital', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Einstein Heart Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospital', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Research Institute', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': 'T6G2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie de Quebec (Hopital Laval)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Annetine C Gelijns, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}, {'name': 'Richard Weisel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Toronto General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair, Department of Population Health Science & Policy, Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR', 'investigatorFullName': 'Annetine Gelijns', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}