XVIVO Heart Perfusion System (XHPS) with Supplemented XVIVO Heart Solution (SXHS)

Recipient Inclusion Criteria:

1. Age ≥18 years.

2. Signed informed consent form (ICF).

3. Listed for heart transplantation

Recipient Exclusion Criteria:

1. Previous solid organ or bone marrow transplantation.

2. Requires a multi-organ transplant.

3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical
device clinical trial (Exception: observational studies are permitted).

4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD,
Impella or intra-aortic balloon pump.

5. History of complex congenital heart disease ie: single ventricle physiology (Per
Investigators discretion).

6. Subject on renal replacement therapy/dialysis.

7. Ventilator dependence (subject is intubated at time of transplant/unable to provide
consent or re-affirmation of consent).

8. Sensitized subject is undergoing desensitization treatment.

Donor Inclusion Criteria:

1. Estimated Cross Clamp Time ≥ 4 hours, OR

2. Estimated Cross Clamp Time ≥ 2 hours, AND

Any ONE or more of the following:

- Age ≥ 50 years

- LVEF 40-50% at time of provisional acceptance

- Down-time ≥ 20 mins

- Hypertrophy/Septal thickness >12- ≤16mm

- Angiographic luminal irregularities with no significant CAD, OR

3. Donation after Circulatory Death (DCD) donors.

Donor Exclusion Criteria:

1. Unstable hemodynamics requiring high-dose inotropic support.

2. Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or
more vessels.

3. Moderate to severe cardiac valve pathology.

4. Investigator's clinical decision to exclude from trial.

5. Previous Sternotomy.