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AbioCor Implantable Replacement Heart

NCT ID: NCT00669357

Last Updated: 2013-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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

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Detailed Description

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Conditions

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Severe Biventricular End Stage Heart Disease

Interventions

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Abiocor Implantable Replacement Heart

Replacement of heart

Intervention Type DEVICE

Eligibility Criteria

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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.
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abiomed Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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H040006

Identifier Type: -

Identifier Source: org_study_id

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