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AbioCor Implantable Replacement Heart
Expanded access is currently available for this treatment.
Verified by Abiomed Inc., April 2008
Sponsored by: Abiomed Inc.
Information provided by: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT00669357
  Purpose

Abiocor is a post market approval study for an Implantable Replacement Heart


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

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources
Study Type: Expanded Access
Official Title: AbioCor Implantable Replacement Heart

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669357

Contacts
Contact: Robert T.V. Kung, PhD 978-646-1400 kungr@abiomed.com

Locations
United States, Indiana
St Vincent Hospital
Indianapolis, Indiana, United States
United States, Maryland
John Hopkins University Hospital
Baltimore, Maryland, United States
United States, New Jersey
Robert Wood Johnson
New Brunswick, New Jersey, United States
United States, Texas
St Lukes @ Texas Heart Institute
Houston, Texas, United States
Sponsors and Collaborators
Abiomed Inc.
Investigators
Study Director: Robert T.V. Kung, PhD Abiomed Inc.
  More Information

Responsible Party: Abiomed Inc ( Robert Kung )
Study ID Numbers: H040006
Study First Received: April 25, 2008
Last Updated: April 29, 2008
ClinicalTrials.gov Identifier: NCT00669357  
Health Authority: United States: Institutional Review Board

Keywords provided by Abiomed Inc.:
End stage heart disease

Study placed in the following topic categories:
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009