XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
NCT ID: NCT06895070
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-10
2031-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
NCT05881278
HOPE At Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.
NCT06485596
An Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure
NCT05140759
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
NCT02091440
Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study
NCT03022708
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Device: Preservation of hearts for transplant.
Device: Preservation of hearts for transplant.
Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Age ³18 years.
2. Signed informed consent form (ICF).
3. Listed for heart transplantation.
To be eligible to participate in this study, the donor heart must meet the following criteria:
1. Estimated Cross Clamp Time ≥4 hours OR
2. 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)
Exclusion Criteria
2. Requires a multi-organ transplant.
3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP).
5. History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
6. Subject on renal replacement therapy/dialysis.
7. Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
8. 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 hearts that meet any of the following criteria will be excluded from transplantation in this study:
1. Unstable hemodynamics requiring high-dose inotropic support.
2. 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.
3. Moderate to severe cardiac valve pathology.
4. Investigator's clinical decision to exclude from trial.
5. Previous sternotomy.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
XVIVO Perfusion
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarah Lowe
Role: STUDY_DIRECTOR
XVIVO Perfusion
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UC San Diego Health
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Washington University - Barnes Jewish Health Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
NYU Langone
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIHP-CAP-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.