XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) (NIHP-CAP-001)

March 16, 2026 updated by: XVIVO Perfusion

PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol

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

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a continuation of the PRESERVE IDE trial to provide additional data evaluating the safety and effectiveness of the XVIVO Heart Assist Transport System. The PRESERVE Continued Access Protocol (CAP) will utilize the XHAT System to preserve donor hearts that may not meet current standard donor heart acceptance criteria with the intention of these hearts being transplanted. The CAP has been implemented to allow patients and physicians access to the XHAT System while a Post-Market Approval (PMA) application is being submitted and reviewed.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Health
        • Contact:
        • Principal Investigator:
          • Mark Kearns, M.D.
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Fardad Esmailian
        • Contact:
      • Los Angeles, California, United States, 90095-1405
        • Recruiting
        • University of California Los Angeles
        • Contact:
        • Contact:
        • Principal Investigator:
          • Abbas Ardehali, M.D.
        • Sub-Investigator:
          • Reshma Biniwale, M.D.
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yasuhiro Shudo, PHD, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Principal Investigator:
          • Mani Daneshmand, M.D.
        • Sub-Investigator:
          • Joshua Chan, M.D.
        • Sub-Investigator:
          • Victor Pretorius
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611-5969
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Benjamin Bryner, M.D.
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University - Barnes Jewish Health Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amit Pawale, M.D.
    • Nebraska
      • Omaha, Nebraska, United States, 69198-2265
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marian Urban, M.D.
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/New York Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Koji Takeda, M.D.
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jacob Schroder, M.D.
        • Sub-Investigator:
          • Jeffrey Keenan, M.D.
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Ashish S Shah, M.D.
    • Texas
      • Dallas, Texas, United States, 75390
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Contact:
        • Principal Investigator:
          • Jay Pal, M.D.

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

Inclusion Criteria Recipient:

To be eligible to participate in this study, a recipient must meet all the following criteria:

  1. Age ³18 years.
  2. Signed informed consent form (ICF).
  3. Listed for heart transplantation.

Exclusion Criteria Recipient:

  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 (IABP).
  5. History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
  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 participants meeting any of the following:

    • Participant with calculated Panel Reactive Antibody (cPRA) greater than 50%
    • Participant undergoing any desensitization treatment (also with cPRA less than 50%)
    • Participant with a positive prospective crossmatch and/or a positive virtual cross match

Donor Inclusion Criteria:

To be eligible to participate in this study, the donor heart must meet the following criteria:

  1. Estimated Cross Clamp Time ≥4 hours OR
  2. Estimated Cross Clamp ≥ 2 hours AND

Any one or more of the following:

  • Age ≥50 years
  • LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance).
  • Down-time ≥20 minutes
  • Hypertrophy septal thickness >12 - ≤16mm
  • Angiographic luminal irregularities with no significant CAD OR 1) Donation after Circulatory Death (DCD)

Donor Exclusion Criteria:

Donor hearts that meet any of the following criteria will be excluded from transplantation in this study:

  1. Unstable hemodynamics requiring high-dose inotropic support.
  2. Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels or if the donor heart exhibits any contusions, structural damage, gross abnormalities, or palpable CAD on final examination.
  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: Device: Preservation of hearts for transplant.
Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
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)

July 10, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIHP-CAP-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

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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