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.
Brief Title
SynCardia Freedom Driver System Study
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Biventricular Failure
Eligibility Criteria
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.
* 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.
Inclusion Criteria
Inclusion Criteria:
* Patients who are implanted with the TAH-t and are clinically stable.
* Patients who are implanted with the TAH-t and are clinically stable.
Gender
All
Gender Based
false
Keywords
Biventricular failure
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
NCT Id
NCT00733447
Org Class
Industry
Org Full Name
SynCardia Systems. LLC
Org Study Id
RA-142
Overall Status
Approved for marketing
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
SynCardia Freedom Driver System Study
Secondary Ids
Secondary Id
P030011
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Daniel Goldstein
Investigator Email
dgoldste@montefiore.org
Investigator Phone