Tests a heart preservation device for donor hearts used in heart transplant
Tests a device that keeps donor hearts preserved during transport for adults needing heart transplant.
Plain-language title generated from the registry record
Registry title: XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
Key facts
- Where
- Atlanta, Chicago, Dallas, Durham, La Jolla, Los Angeles, Nashville, New York, Omaha, Seattle, St Louis, and Stanford, United StatesSee the 14 sites
Where in United States
- Emory University HospitalAtlanta, United StatesTaking people
- Northwestern Memorial HospitalChicago, United StatesTaking people
- University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- Duke University Medical CenterDurham, United StatesTaking people
- UC San Diego HealthLa Jolla, United StatesTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- University of California, Los AngelesLos Angeles, United StatesTaking people
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Columbia University Medical Center/New York-Presbyterian HospitalNew York, United StatesTaking people
- NYU LangoneNew York, United StatesTaking people
- University of Nebraska Medical CenterOmaha, United StatesTaking people
- University of Washington Medical CenterSeattle, United StatesTaking people
- Washington University - Barnes Jewish Health HospitalSt Louis, United StatesTaking people
- Stanford UniversityStanford, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- XVIVO Perfusion
- Trial code
- NCT06895070
- Record updated
- 18 March 2026
- Original description
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.Read full original descriptionShow less
PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol
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.
Inclusion: To be eligible to participate in this study, a recipient must meet all the following criteria:; Age ³18 years; Signed informed consent form (ICF); Listed for heart transplantation.
Exclusion: Previous solid organ or bone marrow transplantation; Requires a multi-organ transplant; Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP); Subject on renal replacement therapy/dialysis; Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent); Angiographic luminal irregularities with no significant CAD OR 1) Donation after Circulatory Death (DCD); Donor Exclusion Criteria:; Donor hearts that meet any of the following criteria will be excluded from transplantation in this study:; Previous sternotomy; History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review); Sensitized participants meeting any of the following:; Participant with calculated Panel Reactive Antibody (cPRA) greater than 50%; Participant undergoing any desensitization treatment (also with cPRA less than 50%); Participant with a positive prospective crossmatch and/or a positive virtual cross match; Donor Inclusion Criteria:; To be eligible to participate in this study, the donor heart must meet the following criteria:; Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels or if the donor heart exhibits any contusions, structural damage, gross abnormalities, or palpable CAD on final examination; Moderate to severe cardiac valve pathology; LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance); Age ≥50 years; Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted); Estimated Cross Clamp Time ≥4 hours OR; Estimated Cross Clamp ≥ 2 hours AND; Any one or more of the following:; Down-time ≥20 minutes; Hypertrophy septal thickness >12 - ≤16mm; Unstable hemodynamics requiring high-dose inotropic support; Investigator's clinical decision to exclude from trial.