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

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