Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

SynCardia Freedom Driver System Study

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
SynCardia Systems. Inc.
ClinicalTrials.gov Identifier:
NCT00733447
First received: August 11, 2008
Last updated: July 1, 2014
Last verified: July 2014

August 11, 2008
July 1, 2014
March 2010
August 2013   (final data collection date for primary outcome measure)
Not Provided
Companion Driver is a suitable replacement for the CSS Console. [ Time Frame: Transplant, 180 days or death ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00733447 on ClinicalTrials.gov Archive Site
Not Provided
Companion Driver can be safely used at home. [ Time Frame: Transplant, 180 days or death ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
SynCardia Freedom Driver System Study
SynCardia Freedom Driver System Study

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.

Not Provided
Expanded Access
Not Provided
Not Provided
Biventricular Failure
Device: CardioWest temporary Total Artificial Heart (TAH-t) System
The SynCardia CardioWest temporary Total Artificial Heart (TAH-t) System is a pulsatile biventricular device that replaces a patient's native ventricles and valves, and pumps blood to both pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external pneumatic driver connected by drivelines.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
Not Provided
May 2014
August 2013   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00733447
RA-142, P030011
Yes
SynCardia Systems. Inc.
SynCardia Systems. Inc.
Not Provided
Not Provided
SynCardia Systems. Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP