XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)

Recipient Inclusion Criteria: Age ≥18 years. Signed informed consent form (ICF). Listed for heart transplantation Recipient Exclusion Criteria: Previous solid organ or bone marrow transplantation. Requires a multi-organ transplant. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted). Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump. History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion). Subject on renal replacement therapy/dialysis. Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent). Sensitized subject is undergoing desensitization treatment. Donor Inclusion Criteria: Estimated Cross Clamp Time ≥ 4 hours, OR Estimated Cross Clamp Time ≥ 2 hours, AND Any ONE or more of the following: Age ≥ 50 years LVEF 40-50% at time of provisional acceptance Down-time ≥ 20 mins Hypertrophy/Septal thickness >12- ≤16mm Angiographic luminal irregularities with no significant CAD, OR Donation after Circulatory Death (DCD) donors. Donor Exclusion Criteria: Unstable hemodynamics requiring high-dose inotropic support. Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels. Moderate to severe cardiac valve pathology. Investigator's clinical decision to exclude from trial. Previous Sternotomy.