For people ages 18 years and up
Part A - DCD Donor Hearts & DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications):
Donor Inclusion Criteria
- 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 Inclusion Criteria
- 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)
Inclusion
- Signed informed consent document and authorization to use and disclose protected health information
- Heart transplant candidate
- Age ≥ 18 years old
Exclusion
• Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial
