Heart EXPAND Continued Access Protocol

Inclusion criteria

(DONOR): At least one of the following: * Expected total cross-clamp time of ≥ 4 hours * Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of \>12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram. Exclusion * CAD with \> 50% stenosis on angiogram, or * Cardiogenic shock or myocardial infarction, or * EF consistently \< 40%, or * Significant valve disease except for competent bicuspid aortic valve. Eligibility Criteria (RECIPIENT) * Registered primary heart transplant candidate * Age \>18 years old * Written informed consent. Exclusion * Prior solid organ or bone marrow transplant * Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal insufficiency requiring dialysis * Multi-organ transplant.