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AbioCor Implantable Replacement Heart

Primary Purpose

Severe Biventricular End Stage Heart Disease

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Abiocor Implantable Replacement Heart
Sponsored by
Abiomed Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Severe Biventricular End Stage Heart Disease focused on measuring End stage heart disease

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 25, 2008
    Last Updated
    May 1, 2013
    Sponsor
    Abiomed Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00669357
    Brief Title
    AbioCor Implantable Replacement Heart
    Official Title
    AbioCor Implantable Replacement Heart
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abiomed Inc.

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Biventricular End Stage Heart Disease
    Keywords
    End stage heart disease

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Abiocor Implantable Replacement Heart
    Intervention Description
    Replacement of heart

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    75 Years
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    AbioCor Implantable Replacement Heart

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