COVID-19 (Coronavirus)

TransMedics Heart DCD CAP

Condition: Heart Transplant

Eligibility

Key Inclusion Criteria (Recipient)

  • Primary heart transplant candidates
  • At least 18 years old
  • Written informed consent, authorization to use and disclose protected health information, and consent to TransMedics’ use of recipients’ data

Key Exclusion Criteria (Recipient)

  • 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

Full Study Name

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) (IRB no. STUDY00001132)

Summary

This study focuses on individuals who have been listed to receive a heart transplant and whose doctor has determined that they may be a suitable candidate for the study. The study aims to evaluate the investigational use of the TransMedics Organ Care System (OCS). The OCS System may be used to preserve hearts obtained from donors after circulatory death (DCD). Researchers will evaluate patients who receive a DCD heart transplant (from donors whose hearts have stopped beating and no longer pump blood). DCD hearts are not used for transplantation in the U.S., but they are used in other countries where the OCS Heart System is commercially available. (In the U.S., donor hearts are currently only obtained from donors after brain death.)
 
Researchers will also evaluate the ability of the OCS Heart System to make more hearts available for transplantation and will monitor post-transplant clinical outcomes.

Principal Investigator

Fardad Esmailian, MD

Contact
Jack Haslett
310-248-7141
jack.haslett@cshs.org