Research Study: EXPAND HEART CAP
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:

The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.
Eligibility Criteria:

Inclusion Criteria (DONOR):

At least one of the following:

  • Expected total cross-clamp time of ≥ 4 hours
  • Expected total cross-clamp time of ≥ 2 hours PLUS one or more of the following risk factors Donor age 45-55 years, inclusive, with no coronary catheterization data; or Donor age ≥ 55 years; or Left ventricular septal or posterior wall thickness of >12 mm, but ≤ 16 mm; or Reported down time of ≥ 20 min, with stable hemodynamics at time of final assessment; or Left heart ejection fraction (EF) ≥ 40%, but ≤ 50% at time of acceptance of offer; or Donor angiogram with luminal irregularities with no significant CAD (≤ 50%); or History of carbon monoxide poisoning with good cardiac function at time of donor assessment; or Social history of alcoholism with good cardiac function at time of donor assessment; or History of diabetes without significant CAD (≤ 50%) on angiogram.

Eligibility Criteria (RECIPIENT)

  • Registered primary heart transplant candidate
  • Age >18 years old
  • Written informed consent. Exclusion
  • 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.

 

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!