Official Title
SynCardia Freedom Driver System Study
Brief Summary

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.

Approved for marketing
Biventricular Failure

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

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.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

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

SynCardia Systems. LLC
NCT Number
Keywords
Biventricular failure
MeSH Terms
Heart Failure