RecruitingNot ApplicableNCT06895070

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

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


Sponsor

XVIVO Perfusion

Enrollment

60 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a device called the XVIVO Heart Box, which is used to keep a donor heart alive and healthy outside the body during transport to a transplant recipient. It uses a special preservation solution to maintain the heart in better condition before surgery. The goal is to continue providing access to this technology while additional safety and effectiveness data are collected. **You may be eligible if...** - You are 18 years or older - You are listed and waiting for a heart transplant - You have signed an informed consent form **You may NOT be eligible if...** - You have previously had a solid organ or bone marrow transplant - You need a transplant of multiple organs at the same time - You are currently enrolled in another investigational study - The donor heart does not meet certain standard criteria (such as age limits or donation after cardiac death criteria) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENon-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)


Locations(14)

UC San Diego Health

La Jolla, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Stanford University

Stanford, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Washington University - Barnes Jewish Health Hospital

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

NYU Langone

New York, New York, United States

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Washington Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06895070


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