SynCardia Freedom Driver System Study
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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 |
Expanded Access Status :
Approved for marketing
First Posted : August 13, 2008
Last Update Posted : July 30, 2015
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Condition or disease | Intervention/treatment |
---|---|
Biventricular Failure | Device: CardioWest temporary Total Artificial Heart (TAH-t) System |
Study Type : | Expanded Access |
Official Title: | SynCardia Freedom Driver System Study |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | August 2013 |
Estimated Study Completion Date : | May 2014 |

- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Responsible Party: | SynCardia Systems. LLC |
ClinicalTrials.gov Identifier: | NCT00733447 |
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 |
Biventricular failure |
Heart Failure Heart Diseases Cardiovascular Diseases |