OCS Solution & OFEEnhancing 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