Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-01-01 @ 10:37 PM
Study NCT ID:
NCT01171950
Status:
WITHDRAWN
Last Update Posted:
2022-06-24
First Post:
2010-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2010-07-27', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant', 'description': 'In patients who recover and do not go on to transplantation or a long-term device:\n\n• Survival 30 days after removal of the CentriMag VAS or to discharge, whichever is longer.\n\nIn patients who do not recover:\n\n• Ability to be removed from the CentriMag VAS and survive to induction of anesthesia for implantation of a long-term device or heart transplantation.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of end-organ function', 'timeFrame': '30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant', 'description': 'Improvements in measures of end-organ function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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 pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 5 years to 16 years, inclusive\n2. Inability to wean from cardiopulmonary bypass (CPB)\n\nExclusion Criteria:\n\n1. Body weight \\< 20 kg\n2. Severe aortic insufficiency\n3. Unrestricted intra-cardiac communications (i.e. large VSD)\n4. Pulmonary vascular resistance index (PVRI) \\> 10 IU\n5. Presence of DIC\n6. On hemodialysis (excluding hemofiltration)\n7. Contraindications to systemic anticoagulation\n8. Active systemic infection unresponsive to antibiotics\n9. Unresolved malignancy\n10. On other investigational VAS'}, 'identificationModule': {'nctId': 'NCT01171950', 'briefTitle': 'CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients', 'orgStudyIdInfo': {'id': 'PED-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All Patients', 'description': 'All patients meeting the patient selection criteria will be treated with the CentriMag device.', 'interventionNames': ['Device: CentriMag Ventricular Assist System']}], 'interventions': [{'name': 'CentriMag Ventricular Assist System', 'type': 'DEVICE', 'description': 'All patients will be treated with the CentriMag device for up to 30 days.', 'armGroupLabels': ['All Patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pooja Chatterjee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Thoratec Corporation/Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Thoratec Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}