Research Study: DCD Heart Trial
Condition:
heart failure/transplant candidate
Study Sponsor: TransMedics
Study Investigator: Karol Mudy, MD
Study Contact: Kari Thomas
kari.m.thomas@allina.com
612-863-7493
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

To 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.
Eligibility Criteria:

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.

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.

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!