XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
NCT ID: NCT05881278
Last Updated: 2025-03-21
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
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ACTIVE_NOT_RECRUITING
NA
141 participants
INTERVENTIONAL
2023-10-10
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Subjects requiring a Heart Transplant
Device: Preservation of hearts for transplant.
Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Interventions
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Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent form (ICF).
3. Listed for heart transplantation
1. Estimated Cross Clamp Time ≥ 4 hours, OR
2. Estimated Cross Clamp Time ≥ 2 hours, AND
Any ONE or more of the following:
* Age ≥ 50 years
* LVEF 40-50% at time of provisional acceptance
* Down-time ≥ 20 mins
* Hypertrophy/Septal thickness \>12- ≤16mm
* Angiographic luminal irregularities with no significant CAD, OR
3. Donation after Circulatory Death (DCD) donors.
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.
5. History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion).
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 subject is undergoing desensitization treatment.
1. Unstable hemodynamics requiring high-dose inotropic support.
2. Significantly abnormal coronary angiogram defined as CAD \> 50% stenosis of one or more vessels.
3. Moderate to severe cardiac valve pathology.
4. Investigator's clinical decision to exclude from trial.
5. Previous Sternotomy.
18 Years
ALL
No
Sponsors
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XVIVO Perfusion
INDUSTRY
Responsible Party
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Principal Investigators
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Jaya Tiwari
Role: STUDY_DIRECTOR
XVIVO Perfusion
Locations
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University of California San Diego
La Jolla, California, United States
Cedars-Sinai
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Stanford Medicine
Palo Alto, California, United States
Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Maryland Medical Center/University of Maryland, Baltimore
Baltimore, Maryland, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
NYU Langone Health
New York, New York, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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NIHP - 001
Identifier Type: -
Identifier Source: org_study_id
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