🏛️ Verified NIH Record • Updated 2026-03-16
XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) (NCT06895070)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: XVIVO Perfusion
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (24 items).
Location: UC San Diego Health — La Jolla, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (14 Sites)
- UC San Diego Health — La Jolla, California
- Cedars Sinai Medical Center — Los Angeles, California
- University of California Los Angeles — Los Angeles, California
- Stanford University — Stanford, California
- Emory University Hospital — Atlanta, Georgia
- Northwestern Memorial Hospital — Chicago, Illinois
- Washington University - Barnes Jewish Health Hospital — St Louis, Missouri
- University of Nebraska Medical Center — Omaha, Nebraska
- NYU Langone — New York, New York
- Columbia University Medical Center/New York Presbyterian Hospital — New York, New York
- Duke University Medical Center — Durham, North Carolina
- Vanderbilt University Medical Center — Nashville, Tennessee
- University of Texas Southwestern Medical Center — Dallas, Texas
- University of Washington Medical Center — Seattle, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.