Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 7:57 AM
Study NCT ID:
NCT00669357
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2013-05-03
First Post:
2008-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AbioCor Implantable Replacement Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-01', 'studyFirstSubmitDate': '2008-04-25', 'studyFirstSubmitQcDate': '2008-04-29', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['End stage heart disease'], 'conditions': ['Severe Biventricular End Stage Heart Disease']}, 'descriptionModule': {'briefSummary': 'Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in severe biventricular end stage heart disease who are not cardiac transplant candidates and who are adults less than 75 years old, require multiple inotropic support, are not treatable by LVAD destination therapy, and are not weanable from biventricular support if on such support.\n\nExclusion Criteria:\n\n* Patients with other irreversible end organ dysfunctions that would compromise survival, having in clinical assessment a more than 30% chance of survival beyond 30 days, inadequate psychosocial support, or patients in whom fit is a problem, based on preoperative noninvasive anatomical assessment showing that the thoracic volume is unable to accommodate the device.'}, 'identificationModule': {'nctId': 'NCT00669357', 'briefTitle': 'AbioCor Implantable Replacement Heart', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abiomed Inc.'}, 'officialTitle': 'AbioCor Implantable Replacement Heart', 'orgStudyIdInfo': {'id': 'H040006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Abiocor Implantable Replacement Heart', 'type': 'DEVICE', 'description': 'Replacement of heart'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abiomed Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}