Ignite Creation Date:
2025-12-18 @ 9:28 AM
Ignite Modification Date:
2025-12-23 @ 8:38 PM
Study NCT ID:
NCT00733447
Status:
None
Last Update Posted:
2015-07-30 00:00:00
First Post:
2008-08-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SynCardia Freedom Driver System Study
Sponsor:
None
Organization:
Study Overview
Official Title:
SynCardia Freedom Driver System Study
Status:
None
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: