Heart EXPAND Continued Access Protocol

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.

To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review.

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.