Trials / Approved For Marketing
Approved For MarketingNCT00733447
SynCardia Freedom Driver System Study
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- SynCardia Systems. LLC · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2013-08-01
- Completion
- 2014-05-01
- First posted
- 2008-08-13
- Last updated
- 2015-07-30
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00733447. Inclusion in this directory is not an endorsement.