AbioCor Implantable Replacement Heart

Expanded access is currently available for this treatment.

Verified March 2012 by Abiomed Inc.

Sponsor:

Information provided by (Responsible Party):

Abiomed Inc.

ClinicalTrials.gov Identifier:

NCT00669357

First received: April 25, 2008

Last updated: March 27, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

March 27, 2012

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00669357 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

AbioCor Implantable Replacement Heart

Official Title ^ICMJE

AbioCor Implantable Replacement Heart

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Expanded Access

Study Phase

Study Design ^ICMJE

Condition ^ICMJE

Severe Biventricular End Stage Heart Disease

Intervention ^ICMJE

Device: Abiocor Implantable Replacement Heart

Replacement of heart

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Available

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Carol Pekar

978-646-1639

cpekar@abiomed.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00669357

Other Study ID Numbers ^ICMJE

H040006

Has Data Monitoring Committee

Responsible Party

Abiomed Inc.

Study Sponsor ^ICMJE

Abiomed Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

Abiomed Inc.

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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