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SynCardia Freedom Driver System Study

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733447
First Posted: August 13, 2008
Last Update Posted: July 30, 2015
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.
Information provided by (Responsible Party):
SynCardia Systems. LLC
August 11, 2008
August 13, 2008
July 30, 2015
 
SynCardia Freedom Driver System Study
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.
Not Provided
Expanded Access
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.
Not Provided
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00733447
SynCardia Systems. LLC
SynCardia Systems. LLC
Not Provided
Not Provided
SynCardia Systems. LLC
July 2015