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AbioCor Implantable Replacement Heart

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ClinicalTrials.gov Identifier: NCT00669357
Recruitment Status : No longer available
First Posted : April 30, 2008
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.

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

Condition or disease Intervention/treatment
Severe Biventricular End Stage Heart Disease Device: Abiocor Implantable Replacement Heart

Study Type : Expanded Access
Official Title: AbioCor Implantable Replacement Heart

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources


Intervention Details:
    Device: Abiocor Implantable Replacement Heart
    Replacement of heart

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

No Contacts or Locations Provided

Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT00669357     History of Changes
Other Study ID Numbers: H040006
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Abiomed Inc.:
End stage heart disease

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases