Clinical Research Directory

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.