The safety endpoints will be captured according to the Intermacs Registry AE definitions and will be assessed according to the same data collection schedule followed under the Intermacs Registry protocol. Secondary safety endpoints will be the incidences of major infection (sepsis), neurological events (ischemic or hemorrhagic cardiovascular accident [CVA]), chronic renal dysfunction, and the rate of major device failures/malfunctions, each defined per the Intermacs definitions. A performance goal for each has been established based on the previous experience of TAH-t patients who were waiting for a heart transplant.