SynCardia Freedom Driver System Study
- Conditions
- Biventricular Failure
- Registration Number
- NCT00733447
- Lead Sponsor
- SynCardia Systems. LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States