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)
The percentage of patient survival — Post-operative Day 365. The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.
The percentage of patient treatment success rate — 30 days post transplantation The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.
Trial sites (20)
Facility
City
Region
Status
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
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.
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