On 2 March 2012, FDA granted a Humanitarian Use Designation (HUD) to the 70cc TAH-t System for use as Destination Therapy (DT) in patients at risk of imminent death from irreversible biventricular heart failure who are not eligible for transplant and have a body surface area (BSA) >1.7m. This clinical study is intended to determine the safety and probable benefit of the 70cc TAH-t for use in DT and support a Humanitarian Device Exemption (HDE) application for this new indication for the TAH-t System.