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SynCardia Freedom Driver System Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00733447
Recruitment Status : Approved for marketing
First Posted : August 13, 2008
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purposes of this study are to confirm that the Freedom Driver System is a suitable pneumatic driver for clinically stable TAH-t subjects, and that patients and lay caregivers can be trained to manage the Freedom Driver System safely outside the hospital.

Condition or disease Intervention/treatment
Biventricular Failure Device: CardioWest temporary Total Artificial Heart (TAH-t) System

Study Design

Study Type : Expanded Access
Official Title: SynCardia Freedom Driver System Study
Study Start Date : March 2010
Primary Completion Date : August 2013
Estimated Study Completion Date : May 2014
Interventions

Intervention Details:
    Device: CardioWest temporary Total Artificial Heart (TAH-t) System
    The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) System is a pulsatile biventricular device that replaces a patient's native ventricles and valves, and pumps blood to both pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external pneumatic driver connected by drivelines.
Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are implanted with the TAH-t and are clinically stable.

Exclusion Criteria:

  • Patients who are implanted with the TAH-t and are not clinically stable.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733447


Locations
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
SynCardia Systems. LLC
More Information

Responsible Party: SynCardia Systems. LLC
ClinicalTrials.gov Identifier: NCT00733447     History of Changes
Other Study ID Numbers: RA-142
P030011
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Keywords provided by SynCardia Systems. LLC:
Biventricular failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases