Status:
APPROVED_FOR_MARKETING
SynCardia Freedom Driver System Study
Lead Sponsor:
SynCardia Systems. LLC
Conditions:
Biventricular Failure
Eligibility:
All Genders
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 man...
Eligibility Criteria
Inclusion
- Patients who are implanted with the TAH-t and are clinically stable.
Exclusion
- Patients who are implanted with the TAH-t and are not clinically stable.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
EXPANDED_ACCESS
End Date :
May 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00733447
Start Date
March 1 2010
End Date
May 1 2014
Last Update
July 30 2015
Active Locations (3)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298