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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
Expanded Access Status : Approved for marketing
First Posted : August 13, 2008
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
SynCardia Systems. LLC

Tracking Information
First Submitted Date August 11, 2008
First Posted Date August 13, 2008
Last Update Posted Date July 30, 2015
 
Descriptive Information
Brief Title SynCardia Freedom Driver System Study
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.
Detailed Description Not Provided
Study Type Expanded Access
Intervention 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00733447
Responsible Party SynCardia Systems. LLC
Study Sponsor SynCardia Systems. LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account SynCardia Systems. LLC
Verification Date July 2015