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

PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).

Recipient Inclusion Criteria:

• Age ≥18 years.
• Signed informed consent form (ICF).
• Listed for heart transplantation

Recipient Exclusion Criteria:

• Previous solid organ or bone marrow transplantation.
• Requires a multi-organ transplant.
• Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
• Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump.
• History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion).
• Subject on renal replacement therapy/dialysis.
• Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
• Sensitized subject is undergoing desensitization treatment.

Donor Inclusion Criteria:

• Estimated Cross Clamp Time ≥ 4 hours, OR
• 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
• Donation after Circulatory Death (DCD) donors.

Donor Exclusion Criteria:

• Unstable hemodynamics requiring high-dose inotropic support.
• Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels.
• Moderate to severe cardiac valve pathology.
• Investigator's clinical decision to exclude from trial.
• Previous Sternotomy.