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Clinical Trials in the USA / NCT05881278
Active, not recruiting Not applicable

XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)

NCT05881278 · tracked via the Priya Life Science USA tracker
Sponsor
XVIVO Perfusion
Phase
Not applicable
Started
2023-10-10
Last updated
2026-08-17

Condition(s) studied

Heart FailureTransplant; Failure, Heart

Investigational drug(s) / intervention(s)

Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)

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)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Recipient Inclusion Criteria: 1. Age ≥18 years. 2. Signed informed consent form (ICF). 3. Listed for heart transplantation Recipient Exclusion Criteria: 1. Previous solid organ or bone marrow transplantation. 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. Donor Inclusion Criteria: 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. Donor Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
University of California San Diego La Jolla California
Cedars-Sinai Los Angeles California
David Geffen School of Medicine at UCLA Los Angeles California
Stanford Medicine Palo Alto California
Emory University Atlanta Georgia
Northwestern Memorial Hospital Chicago Illinois
University of Maryland Medical Center/University of Maryland, Baltimore Baltimore Maryland
Johns Hopkins Medicine Baltimore Maryland
Washington University - Barnes Jewish Hospital St Louis Missouri
University of Nebraska Medical Center Omaha Nebraska
NYU Langone Health New York New York
Columbia University Irving Medical Center/New York Presbyterian Hospital New York New York
Montefiore Medical Center The Bronx New York
Duke University Durham North Carolina
Cleveland Clinic Foundation Cleveland Ohio
Ohio State University Columbus Ohio
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Vanderbilt University Nashville Tennessee
UT Southwestern Medical Center Dallas Texas
University of Washington Medical Center Seattle Washington

More XVIVO Perfusion trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05881278 on ClinicalTrials.gov ↗ ← All trials in the USA