SynCardia Freedom Driver System Study

APPROVED_FOR_MARKETING

Conditions studied: Biventricular Failure

In brief

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.

Key facts

Study ID

NCT00733447

Run by

SynCardia Systems. LLC

Starts

2010-03-01

Expected to finish

2014-05-01

Last updated by the study team

2015-07-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are implanted with the TAH-t and are clinically stable.

You may not qualify if…

• Patients who are implanted with the TAH-t and are not clinically stable.

Where it is running

• 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

Full record on ClinicalTrials.gov

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