Trials / Completed
CompletedNCT00614510
SynCardia CardioWest TAH-t Postmarket Surveillance Study
The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 196 (actual)
- Sponsor
- SynCardia Systems. LLC · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CardioWest temporary Total Artificial Heart (TAH-t) | 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 the pulmonary and systemic circulation. The system consists of the implantable CardioWest TAH-t and an external console connected by drivelines. |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2008-02-13
- Last updated
- 2015-07-30
Source: ClinicalTrials.gov record NCT00614510. Inclusion in this directory is not an endorsement.