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AbioCor Implantable Replacement Heart

AbioCor Implantable Replacement Heart

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00669357
Enrollment
Unknown
Registered
2008-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2013-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Biventricular End Stage Heart Disease

Keywords

End stage heart disease

Brief summary

Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.

Interventions

DEVICEAbiocor Implantable Replacement Heart

Replacement of heart

Sponsors

Abiomed Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
No minimum to 75 Years

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026