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

August 13, 2026 updated by: XVIVO Perfusion

PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).

Study Type

Interventional

Enrollment (Estimated)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California San Diego
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA
      • Palo Alto, California, United States, 94304
        • Stanford Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medicine
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center/University of Maryland, Baltimore
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University - Barnes Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center/New York Presbyterian Hospital
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects requiring a Heart Transplant
Device: Preservation of hearts for transplant.
Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of patient survival
Time Frame: 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.
Post-operative Day 365.
The percentage of patient treatment success rate
Time Frame: 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.
30 days post transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XVIVO Perfusion

Investigators

  • Study Director: Sarah Lowe, XVIVO Perfusion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Actual)

November 22, 2025

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIHP - 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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