Mass General - Division of Clinical Research

Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

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.

Exclusion

- CAD with > 50% stenosis on angiogram, or

- Cardiogenic shock or myocardial infarction, or

- EF consistently < 40%, or

- Significant valve disease except for competent bicuspid aortic valve.

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.