XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
NIHP-CAP-001
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
1 other identifier
interventional
60
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2025
CompletedFirst Posted
Study publicly available on registry
March 26, 2025
CompletedStudy Start
First participant enrolled
July 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2031
ExpectedMarch 18, 2026
February 1, 2026
10 months
March 18, 2025
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
The percentage of patient treatment success rate
The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.
30 days post transplantation
The percentage of patient survival
The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.
Post-operative Day 365.
Study Arms (1)
Device: Preservation of hearts for transplant.
EXPERIMENTALDevice: Preservation of hearts for transplant.
Interventions
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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:
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XVIVO Perfusionlead
Study Sites (14)
UC San Diego Health
La Jolla, California, 92037, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
University of California Los Angeles
Los Angeles, California, 90095-1405, United States
Stanford University
Stanford, California, 94305, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611-5969, United States
Washington University - Barnes Jewish Health Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 69198-2265, United States
NYU Langone
New York, New York, 10016, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sarah Lowe
XVIVO Perfusion
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2025
First Posted
March 26, 2025
Study Start
July 10, 2025
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2031
Last Updated
March 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share