Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation

Inclusion Criteria:

Recipient Day of Transplant

- Registered male or female primary heart transplant candidate

- ≥18 years old

- Signed, written informed consent document and authorization to use and disclose
protected health information

Donor Hearts

- <60 years old

- Mean systolic blood pressure >60 mmHg at the time of final heart assessment

- Satisfactory echocardiography assessment defined as:

- Ejection fraction >40%

- Absence of severe segmental wall motion abnormalities

- Absence of left ventricular hypertrophy (inter ventricular septum and posterior wall
thickness <1.3 cm)

- Absence of valve abnormalities (trace to mild valvular regurgitation is acceptable)

Exclusion Criteria:

Recipient Day of Transplant

- >4 previous sternotomies

- Chronic renal failure as defined by chronic serum creatinine >3.0 mg/dL for more than
2 weeks and/or requiring hemodialysis (except for hemodialysis or hemofiltration for
fluid overload)

- Ventilator dependence at the time of transplant

- Use of a ventricular assist device for > 30 days and the presence of any of the
following: sepsis, intracranial hemorrhage or heparin induced thrombocytopenia

- Panel reactive antibodies > 40% with a positive prospective cross match and/or virtual
cross match

- Use of an investigational drug or device, other than OCS, during the study.

- Simultaneous transplant of non-heart allograft, except for concurrent kidney
transplant

Donor Hearts

- Abnormal coronary angiogram defined as >50% stenosis, requiring coronary bypass

- Donor-to-recipient body weight ratio of <0.6

- Inotrope support at time of final heart assessment including, but not limited to:

- Dopamine >10 ug/kg/min

- Dobutamine > 10 ug/kg/min

- Milrinone >0.3 ug/kg/min

- Epinephrine > 0.03 ug/kg/min

- Norepinephrine > 0.03 ug/kg/min

- Any bolus dose of the above prior to explants that would result in exceeding the
above stated criteria

- Presence of any exclusion criterion based on the standard practice of the
investigational site