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

Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use

The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.

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