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

NCT05881278

Active Not RecruitingNA

Sponsor: XVIVO Perfusion

Conditions: Heart Failure, Transplant; Failure, Heart

Interventions: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (20)
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • New York, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Seattle, Washington, United States