Enhancing Heart Allograft Function With the OCS Heart System Trial

Inclusion Criteria25

• Part A - DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications):
• Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
• All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is <50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor.
• DBD donor hearts with an expected cross clamp of ≥ 4 hours
• DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time:
• Donor age ≥ 40 years old
• Unknown downtime
• Insignificant CAD
• LVEF ≤ 50%
• Donor Exclusion • Moderate to severe aortic incompetence
• Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication):
• Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
• Eligible for randomization to OCS or SCS treatment arms.
• DBD donor hearts with an expected cross clamp time of < 4 hours.
• Donor Exclusion
• Moderate to severe aortic incompetence
• DBD donor with any of the following organ quality concerns:
• Donor age ≥ 40 years old
• Unknown downtime
• Insignificant CAD
• LVEF ≤ 50%
• Recipient Eligibility Criteria (for Part A and B Cohorts)
• Signed informed consent document and authorization to use and disclose protected health information
• Heart transplant candidate
• Age ≥ 18 years old