Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT00819793
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2009-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'psood@sjm.com', 'title': 'Poornima Sood', 'organization': 'Abbott'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From CentriMag implant, during support, and for 6 months post device-removal', 'eventGroups': [{'id': 'EG000', 'title': 'Patients Supported by the CentriMag Ventricular Assist System', 'description': 'All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.\n\nBlood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 15, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Other adverse events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Major bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 73, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial fluid collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Major infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 22, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurologic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial non-CNS thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other adverse event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Supported by the CentriMag Ventricular Assist System', 'description': 'All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.\n\nBlood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant', 'description': 'Number of patients alive 30 days after device implantation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Supported With CentriMag'}], 'classes': [{'title': 'CVP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Mean arterial pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '11.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP', 'description': 'Change in mean CVP while on pump support and in MAP during pump support. CVP and MAP were measured daily during pump support and the mean CVP and MAP during pump support were compared to baseline. Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'measurements not made in all subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Supported by the CentriMag Ventricular Assist System', 'description': 'All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.\n\nBlood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Protocol included an enrollment allowance of 30 subjects at 25 centers for subjects who fail to wean from cardiopulmonary bypass. 2 additional patients were enrolled to increase the number of LVAD use in the study. Subject enrollment commenced in October 2008. A total of 18 sites participated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CentriMag Ventricular Assist System', 'description': 'All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.\n\nCentriMag Ventricular Assist System: All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '58', 'spread': '13.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History', 'classes': [{'title': 'Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Hyperlipidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}, {'title': 'Prior Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Prior Cardiovascular Events examples include Arrhythmias, Valve repair or replacement, myocardial infarction, coronary artery bypass grafting (CABG), etc.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity/Race', 'classes': [{'title': 'African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Native American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Heart Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '91.1', 'spread': '21.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Laboratory Values', 'classes': [{'title': 'Blood Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.1', 'spread': '21.3', 'groupId': 'BG000'}]}]}, {'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.8', 'groupId': 'BG000'}]}]}, {'title': 'Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.8', 'groupId': 'BG000'}]}]}, {'title': 'Plasma Free Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28.8', 'spread': '28.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Some lab values not submitted for all patients'}, {'title': 'Hemodynamic Values', 'classes': [{'title': 'Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '98.6', 'spread': '23.2', 'groupId': 'BG000'}]}]}, {'title': 'Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54.2', 'spread': '12.7', 'groupId': 'BG000'}]}]}, {'title': 'Pulmonary Artery Systolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37.3', 'spread': '14.0', 'groupId': 'BG000'}]}]}, {'title': 'Pulmonary Artery Diastolic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22.9', 'spread': '8.5', 'groupId': 'BG000'}]}]}, {'title': 'Central Venous Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Hemodynamics were unable to be collected on all patients'}, {'title': 'Glasgow Coma Scale', 'classes': [{'title': 'Eye Opening : Not done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Eye Opening : No response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Eye Opening : Response to speech', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Eye Opening : Spontaneous eye opening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Motor response: Not done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Motor response: No response to pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Motor response: Withdrawal to pain stimuli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Motor response: Localizes pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Motor response: Obeys commands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Verbal response: Not done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Verbal response: No verbalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Verbal response: Normal conversation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Surface Area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.05', 'spread': '0.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Meters squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cardiac Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'L/min/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Hemodynamics were unable to be collected on all patients'}, {'title': 'Cardiac Output', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'L/min', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Hemodynamics were unable to be collected on all patients'}, {'title': 'Respiratory Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '17.6', 'spread': '6.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Respiratory rate data not submitted for two patients'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'dispFirstSubmitDate': '2014-05-30', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2009-01-08', 'dispFirstSubmitQcDate': '2014-10-30', 'resultsFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2009-01-08', 'dispFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-28', 'studyFirstPostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '30 days post-support or to hospital discharge, whichever is longer OR to induction of anesthesia for implantation of a long-term device or heart transplant', 'description': 'Number of patients alive 30 days after device implantation'}], 'secondaryOutcomes': [{'measure': 'Improvement in Central Venous Pressure (CVP) and Mean Arterial Blood Pressure (MAP)', 'timeFrame': 'Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP', 'description': 'Change in mean CVP while on pump support and in MAP during pump support. CVP and MAP were measured daily during pump support and the mean CVP and MAP during pump support were compared to baseline. Mean CVP or MAP during support (up to 30 days) minus baseline CVP or MAP.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac Dysfunction', 'Failure-to-wean from CPB', 'CentriMag', 'Levitronix', 'Thoratec Corporation'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Cardiac dysfunction due to failure-to-wean from cardiopulmonary bypass\n* Subjects who are on IABP, CPB, ECMO or CPS support prior to evaluation should have the device turned off, if possible, for the purpose of measuring inclusion hemodynamics. However, these devices should not be turned off in patients who would be harmed by interruption of support.\n* All subjects must meet the following criteria at the time of enrollment:\n* Hemodynamics:\n\n 1. cardiac index ≤ 2.2 L/min/m2\n 2. For patients being evaluated for left-sided support (LVAD): PCWP ≥ 18 mmHg or PADP ≥ 18 mmHg or LAP ≥ 18 mmHg\n 3. For patients being evaluated for right or biventricular support: CVP ≥ 15 mmHg or RAP ≥ 15 mmHg and RVSWI ≤ 4.1 gm/m2/beat\n 4. Enrollment without hemodynamic measurements due to frequent or unpredictable dysrhythmias, unacceptable cardiac function, or hemodynamic instability is allowed.\n* Placement of an intra-aortic balloon pump has been attempted unless contraindicated\n* All possible measures have been attempted to correct low arterial pH, arterial blood gas abnormalities, electrolytes, hypovolemia, hypervolemia, inadequate cardiac rate, dysrhythmias and residual hypothermia\n* Cardiac resuscitation using pharmacologic agents, and epicardial pacing (if appropriate and possible) has been attempted\n* Written, signed, and dated informed consent\n\nExclusion Criteria:\n\n* BUN \\> 100 mg/dl\n* Creatinine \\> 5 mg/dl\n* Presence of any investigational mechanical circulatory support device\n* Known history of liver cirrhosis or portal hypertension\n* Pulmonary infarction\n* Stroke, TIA or history of either condition within the last six months and/or any confirmed, existing neurologic deficits\n* Active systemic infection defined as positive blood cultures, core temperature \\>100.5 degrees, white blood count \\> 12,500, and treatment with antimicrobials\n* Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study\n* Other serious disease(s) limiting life expectancy'}, 'identificationModule': {'nctId': 'NCT00819793', 'briefTitle': 'CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Thoratec CentriMag VAS Failure-to-Wean From Cardiopulmonary Bypass Trial', 'orgStudyIdInfo': {'id': 'LXP-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CentriMag Ventricular Assist System', 'description': 'All patients meeting the patient selection criteria will be treated with the CentriMag Ventricular Assist System.', 'interventionNames': ['Device: CentriMag Ventricular Assist System']}], 'interventions': [{'name': 'CentriMag Ventricular Assist System', 'type': 'DEVICE', 'description': 'All eligible subjects will receive the CentriMag Ventricular Assist System. The system is comprised of a single-use centrifugal blood pump, a motor, a primary drive console, a back up drive console and cannulae. Blood from the failing heart is directed from the ventricle or the atrium to the inlet of the pump via an inlet cannula. Blood exits through the outlet port of the pump through the outlet cannula ultimately to the pulmonary or systemic circulation. The system can be used in either a right, left or biventricular configuration.', 'armGroupLabels': ['CentriMag Ventricular Assist System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview University Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Columbia Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Episcopal", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Pooja Chatterjee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Medical Devices'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Thoratec Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}