Syncardia 50cc Temporary Total Artificial Heart Transplant Study

Condition: Heart failure

Eligibility

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)

Summary

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.


Principal Investigator

Alfred Trento, MD

Contact