RecruitingNot ApplicableNCT07230886

Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction

Sponsor

University Health Network, Toronto

Enrollment

50 participants

Start Date

Apr 17, 2026

Study Type

INTERVENTIONAL

Conditions

Primary Graft Dysfunction

Summary

The goal of this clinical trial is to test the feasibility of the study protocol comparing a novel temperature control system - Xo Port Organ Preservation System - to static ice for heat preservation for Heart Transplant. The main questions of the study are as follows: Does the Incidence of severe PGD change within the first 24 hours of heart transplant in patients randomized to the Xo Port Organ Preservation System? Was there a change in composite efficacy endpoints in participants randomized to the Xo Port Organ Preservation System compared to static ice storage? Were the feasibility outcomes achieved? Were there any protocol deviations? Participants will: Be randomized to either the Xo Port Organ Preservation System or static ice storage. Complete a questionnaire at the time of screening, day 0, 7, and 90 days post transplant. Have blood drawn - with their standard of care blood draws - after their transplant, the day after, and 7 days post transplant.

Eligibility

Min Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Standard of Care - Ice packs and a medical device called Xo Port Organ Preservation System for people with primary graft dysfunction. The study is currently recruiting participants at 1 location.

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

DEVICEXo Port Organ Preservation System

It is a disposable temperature-controlled hypothermic transportation system that maintains the donated heart temperature between 8 and 12°C. It consists of an insulated chamber; eutectic gel packs containing a specialized phase change material (composition under manufacturer's patent) preconditioned before use (by freezing in a 4°C temperature-regulated refrigerator for 48 hours), which maintain temperature between 8 and 12°C through passive cooling; a removable insert, a cradle to hold the organ bag, an internal temperature probe; a logger for continuous monitoring and maintenance of temperature over an extended period of time, an internal venting system that allows air circulation to ensure homogenous temperature for a validated maximal time of 24 hours; and casters and a telescopic handle to facilitate transport.

DEVICEStandard of Care - Ice packs

Cold static donor heart preservation is currently the mainstay of organ transportation after procurement. The donor heart is placed in the Traferox Transport system with ice-packs.