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Trial record 1 of 1 for:    NCT00669357
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AbioCor Implantable Replacement Heart

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT00669357
First received: April 25, 2008
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Severe Biventricular End Stage Heart Disease
Device: Abiocor Implantable Replacement Heart

Study Type: Expanded Access     What is Expanded Access?
Official Title: AbioCor Implantable Replacement Heart

Resource links provided by NLM:


Further study details as provided by Abiomed Inc.:

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

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT00669357     History of Changes
Other Study ID Numbers: H040006
Study First Received: April 25, 2008
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abiomed Inc.:
End stage heart disease

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014