Donor After Circulatory Death Heart CAP Trial

The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)

The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)

To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

Recipient Inclusion Criteria:

• • 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' UNOS/OPTN data and recipients' 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.