Trial Search Results
Heart EXPAND Continued Access Protocol
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.
Stanford is currently accepting patients for this trial.
- Device: OCS Heart System
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.
- 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study