The study design is a prospective, non-randomized, two-treatment arm, multi-center study. Nineteen (19) patients will be enrolled in the Primary Arm at up to 30 investigational sites to support an HDE for the use of the TAH-t as DT. Up to an additional 19 patients may be enrolled in the Secondary Arm to futher characterize the use of the TAH-t for DT in a broader patient population.