Ensayos clínicos

Donor Inclusion Criteria:

• 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 Criteria:

• Previous cardiac surgery.
• Known coronary artery disease.
• Cardiogenic shock or myocardial infarction.
• Sustained terminal ejection fraction (EF) of ≤ 50%.
• Significant valve disease except for competent bicuspid aortic valve.

Recipient Inclusion Criteria:

• Primary heart transplant candidates. 
• Age ≥ 18 years old.
• Signed:
  • written informed consent document; 
  • authorization to use and disclose protected health information; and
  • 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 Criteria:

• 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.