No longer availableExpanded AccessUpdated May 3, 2013
AbioCor Implantable Replacement Heart
AbioCor Implantable Replacement Heart
ClinicalTrials.gov ID
NCT00669357
Lead Sponsor
Abiomed Inc.INDUSTRY
Overall Status
No longer available
Study Type
Expanded Access
Last Update Posted
May 3, 2013Estimated
Official Title
AbioCor Implantable Replacement Heart
Brief Summary
Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.
Severe Biventricular End Stage Heart Disease
Abiocor Implantable Replacement Heart
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No data available
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.