XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors
1 other identifier
interventional
141
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Oct 2023
Longer than P75 for not_applicable heart-failure
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2023
CompletedFirst Posted
Study publicly available on registry
May 31, 2023
CompletedStudy Start
First participant enrolled
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
ExpectedApril 1, 2026
March 1, 2026
2.1 years
May 18, 2023
March 31, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
The percentage of patient survival
The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.
Post-operative Day 365.
The percentage of patient treatment success rate
The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.
30 days post transplantation
Study Arms (1)
Subjects requiring a Heart Transplant
EXPERIMENTALDevice: Preservation of hearts for transplant.
Interventions
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation
You may not qualify if:
- Previous solid organ or bone marrow transplantation.
- Requires a multi-organ transplant.
- Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
- Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump.
- History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion).
- Subject on renal replacement therapy/dialysis.
- Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
- Sensitized subject is undergoing desensitization treatment.
- Estimated Cross Clamp Time ≥ 4 hours, OR
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XVIVO Perfusionlead
Study Sites (20)
University of California San Diego
La Jolla, California, 92037, United States
Cedars-Sinai
Los Angeles, California, 90048, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
Stanford Medicine
Palo Alto, California, 94304, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Maryland Medical Center/University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Johns Hopkins Medicine
Baltimore, Maryland, 21287, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
NYU Langone Health
New York, New York, 10016, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jaya Tiwari
XVIVO Perfusion
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2023
First Posted
May 31, 2023
Study Start
October 10, 2023
Primary Completion
November 22, 2025
Study Completion (Estimated)
November 1, 2029
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share