A Study to Evaluate the Effectiveness of The Portable Organ Care System (OCS™) Heart from Donors After Circulatory Death Heart

Overview

About this study

The purpose of this study is o evaluate the effectiveness 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Si Pham, M.D.

Closed for enrollment

Contact information:

FL General Clinical Studies Unit (GCSU)

(904) 953-2255

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available