Status:
NO_LONGER_AVAILABLE
AbioCor Implantable Replacement Heart
Lead Sponsor:
Abiomed Inc.
Conditions:
Severe Biventricular End Stage Heart Disease
Eligibility:
All Genders
Up to 75 years
Brief Summary
Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00669357
Last Update
May 3 2013
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