SynCardia Freedom Driver System Study

Syncardia

Status

Conditions: Biventricular Failure

Treatments: Device: CardioWest temporary Total Artificial Heart (TAH-t) System

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00733447

P030011

RA-142

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.