Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation

A Prospective, Randomized, Single Blind, Multicenter Phase III Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation

The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.

Inclusion Criteria:

Donor criteria:

• deceased donors should fulfil the criteria for organ donation (SCD) Patient criteria
• recipients awaiting their first transplant
• recipients ≥ 18 and >/= 65 years
• recipient's signed informed consent
• waiting list

Exclusion Criteria:

Donor criteria:

• not applicable

Patient criteria:

• recipients participating in another interventional study
• pregnant or lactating patients
• history/demonstration of HIV antibodies or AIDS
• multiorgan transplantation
• transMedics pump
• the explantation team is affiliated another clinic than transplantation team