Syncardia 50cc Temporary Total Artificial Heart Transplant Study
Condition: Heart failure
Key Inclusion Criteria
- At imminent risk of death from biventricular heart failure
- Two functional atrioventricular valves
- Body surface area of 1.2m2 through 1.85 m2
- Adequate sternum to T10 distance OR adequate room in chest
Key Exclusion Criteria
- Patients who are not eligible for cardiac transplant. Cardiac transplant-eligible patients:
- Who cannot be adequately anticoagulated on the TAH-T
- With insufficient space in the chest
- Patients on extracorporeal membrane oxygenation support for more than three days
Full Study Name
Syncardia 50cc Temporary Total Artificial Heart (TAH-T) as a Bridge to Transplant (BTT) (IRB no. 40450)
The purpose of this study is to evaluate whether the Syncardia 50cc Temporary Total Artificial Heart (TAH-T) can support patients who are eligible for heart transplantation and for whom another model of the device (70cc TAH-T) is not appropriate due to the size of the chest cavity (i.e., it would not fit safely in the chest). The device is designed as a bridge (temporary solution) to transplant for patients who are at risk of imminent death due to irreversible, complete heart failure while waiting for a donor heart.
The larger 70cc TAH-T model is approved by the U.S. Food and Drug Administration for use as a bridge to transplant; the smaller 50cc TAH-T model is an investigational device.