Mass General - Division of Clinical Research

Eligibility

Eligible Ages

Over 18 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

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