Biventricular Failure
Conditions
Brief 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.
Interventions
DEVICECardioWest 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.
Sponsors
SynCardia Systems. LLC
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The TAH-t is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
Exclusion criteria
* Patients who are not cardiac transplant eligible. * Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas \<1.7m², or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) \< 10 cm. * Patients who cannot be adequately anticoagulated on the TAH-t.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject survival at 30-days and one-year post transplant | 30-days and one-year post transplant |
Outcome results
None listed