for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
completion around
Principal Investigator
by Victor Pretorius, MD



The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.

Official Title

PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors


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).


Heart Failure, Transplant; Failure, Heart, Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)


For people ages 18 years and up

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.


  • University of California San Diego accepting new patients
    La Jolla California 92037 United States
  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSD


accepting new patients
Start Date
Completion Date
XVIVO Perfusion
Study Type
Expecting 141 study participants
Last Updated