The purposes of this study are to confirm that the Freedom Driver System is a suitablepneumatic driver for clinically stable TAH-t subjects, and that patients and laycaregivers can be trained to manage the Freedom Driver System safely outside thehospital.
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.
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.
Mayo Clinic Hospital
Phoenix, Arizona, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States