Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent 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.

Conditions

• Primary Graft Dysfunction

Interventions

DEVICE

Xo 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.

DEVICE

Standard 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.

Sponsors & Collaborators

• CareDx

  collaborator INDUSTRY

• Montreal Heart Institute

  collaborator OTHER

• London Health Sciences Centre

  collaborator OTHER

• Ottawa Heart Institute Research Corporation

  collaborator OTHER

• Traferox Technology Inc.

  collaborator UNKNOWN

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Yasbanoo Moayedi, MD · University Health Network, Toronto

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-17

Primary Completion

2028-03-31

Completion

2028-12-31

Countries

• Canada

Study Locations