SynCardia Freedom Driver System Study

Status

APPROVED_FOR_MARKETING

Phases

Unknown

Study type

Expanded Access

Source

ClinicalTrials.gov

Registry ID

NCT00733447

Enrollment

Unknown

Registered

2008-08-13

Start date

2010-03-31

Completion date

2014-05-31

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biventricular Failure

Keywords

Biventricular failure

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.

Interventions

DEVICECardioWest 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

Sex/Gender

ALL

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026