Actively Recruiting
XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
Led by XVIVO Perfusion · Updated on 2026-03-18
60
Participants Needed
14
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent form
- Listed for heart transplantation
You will not qualify if you...
- Previous solid organ or bone marrow transplantation
- Requires a multi-organ transplant
- Enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (except observational studies)
- On mechanical circulatory support pre-transplant other than durable LVAD, Impella, or intra-aortic balloon pump
- History of complex congenital heart disease such as single ventricle physiology
- On renal replacement therapy or dialysis
- Ventilator dependent and unable to provide or reaffirm consent
- Sensitized participants with calculated Panel Reactive Antibody (cPRA) greater than 50%, undergoing desensitization treatment, or with positive prospective or virtual crossmatch
- Donor hearts with unstable hemodynamics requiring high-dose inotropic support
- Donor hearts with significant coronary artery disease or structural damage
- Moderate to severe cardiac valve pathology in donor hearts
- Investigator's clinical decision to exclude from trial
- Previous sternotomy in donor hearts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
UC San Diego Health
La Jolla, California, United States, 92037
Actively Recruiting
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90095-1405
Actively Recruiting
4
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
5
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611-5969
Actively Recruiting
7
Washington University - Barnes Jewish Health Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
8
University of Nebraska Medical Center
Omaha, Nebraska, United States, 69198-2265
Actively Recruiting
9
NYU Langone
New York, New York, United States, 10016
Actively Recruiting
10
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
11
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
12
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
14
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
A
Amanda Carpenter
CONTACT
J
Jen Ruel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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