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XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)

XVIVO Perfusion · NCT06895070

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
14
Study start
July 10, 2025
Record last updated
March 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)

Conditions: Heart Transplant; Heart Failure; Transplant; Failure, Heart

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria Recipient

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 Criteria Recipient

  • 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 (IABP).
  • History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
  • 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 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:

  • Estimated Cross Clamp Time ≥4 hours OR
  • Estimated Cross Clamp ≥ 2 hours AND

Any one or more of the following

  • Age ≥50 years
  • LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance).
  • Down-time ≥20 minutes
  • Hypertrophy septal thickness >12 - ≤16mm
  • 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:

  • Unstable hemodynamics requiring high-dose inotropic support.
  • 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.
  • Investigator's clinical decision to exclude from trial.
  • Previous sternotomy.

Recruiting US locations

  • UC San Diego Health

    La Jolla, CA 92037

    Site contact: Andrew Stewart · 858-534-3793 · a9stewart@health.ucsd.edu

  • Cedars Sinai Medical Center

    Los Angeles, CA 90048

    Site contact: Jeremy Duenas · 310-248-7193 · Jeremy.Duenas@csmns.org

  • University of California Los Angeles

    Los Angeles, CA 90095-1405

    Site contact: Tahera Alnaseri · 425-435-0216 · Talnaseri@mednet.ucla.edu

  • Stanford University

    Stanford, CA 94305

    Site contact: Lasemahang Limbu · 650-387-5852 · limbul@stanford.edu

  • Emory University Hospital

    Atlanta, GA 30322

    Site contact: Emily Temponi · 404-712-1787 · emily.k.temponi@emoryhealthcare.org

  • Northwestern Memorial Hospital

    Chicago, IL 60611-5969

    Site contact: Allison Mossell · 773-354-0756 · Allison.mossell@nm.org

  • Washington University - Barnes Jewish Health Hospital

    St Louis, MO 63110

    Site contact: James Hermeyer · 636-383-1721 · hermeyer.j@wustl.edu

  • University of Nebraska Medical Center

    Omaha, NE 69198-2265

    Site contact: Mia Morrissey, M.S. · 402-559-4601 · mmorrissey1@unmc.edu

  • NYU Langone

    New York, NY 10016

    Site contact: Jacquline Bott · jacqueline.bolt@nyulangone.org

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, NY 10032

    Site contact: Bo Lu · 212-305-3009 · bl2699@cumc.columbia.edu

  • Duke University Medical Center

    Durham, NC 27710

    Site contact: Rachel Rice · 919-602-3387 · rachel.s.rice@duke.edu

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Lisa Slinger · 615-875-2602 · lisa.slinger@vumc.org

  • University of Texas Southwestern Medical Center

    Dallas, TX 75390

    Site contact: Sarah McNeil · 214-645-7728 · sarah.mcneil@utsouthwestern.edu

  • University of Washington Medical Center

    Seattle, WA 98195

    Site contact: Shauna Andrus · 206-953-9970 · sandrus@uw.edu

Study contacts (from the official record)

  • Amanda Carpenter · 617-283-8332 · Amanda.Carpenter@xvivogroup.com
  • Jen Ruel · jen.ruel@xvivogroup.com
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XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution… (NCT06895070) | Bored Studies