Donors After Circulatory Death Heart Trial

Donor Inclusion

   - Maastricht Category III DCD donor, defined as expected death after the withdrawal of
   life- supportive therapy (WLST)

   - Donor age 18-49 years old inclusive

   - Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when
   mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to
   aortic cross-clamp and administration of cold cardioplegia in the donor.

Donor Exclusion

   - Previous cardiac surgery

   - Known coronary artery disease

   - Cardiogenic shock or myocardial infarction, or

   - Sustained terminal ejection fraction (EF) of ≤ 50%, or

   - Significant valve disease except for competent bicuspid aortic valve

Recipient Inclusion

   - Primary heart transplant candidates

   - Age ≥ 18 years old

   - Signed: (1) written informed consent document; (2) authorization to use and disclose
   protected health information; and (3) consent to TransMedics' use of recipients'
   United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network
   (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory
   Support (INTERMACS) data.

Recipient Exclusion

   - Prior solid organ or bone marrow transplant

   - Chronic use of hemodialysis or diagnosis of chronic renal insufficiency

   - Multi-organ transplant

   - Investigator unwilling to randomize to either arm.