Enhancing Heart Allograft Function With the OCS Heart System Trial

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