Recruiting

Xo Port

Sponsor:

University Health Network, Toronto

Code:

NCT07230886

Conditions

Primary Graft Dysfunction

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Interventions

Xo Port Organ Preservation System

Standard of Care - Ice packs

Study Details

Brief 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

Study ID

NCT07230886

Start date

Apr 17, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Recipient: Adult (>17 years old)
  • Donor: Donation after brain death acceptable for transplant as determined by a procuring physician unaware of randomization sequence at the time of acceptance

Exclusion Criteria:

  • Recipient: Multi-organ transplant recipients; Participating in an interventional study.
  • Donor: Donation after cardiac death; Use of organ care system

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Xo Port Organ Preservation System

Traferox Transport System containing eutectic gel-packs used for controlled hypothermic storage

active comparator: Static Ice Storage

Traferox Transport System containing ice-packs as used for conventional cold static storage

Interventions

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.

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.

Primary outcome measure

  • Primary Study Feasibility [ Time Frame: 2.5 years ]
  • Composite efficacy outcome of full-scare trial #1 [ Time Frame: 2.5 years ]
  • Composite efficacy outcome of full-scare trial #2 [ Time Frame: 2.5 years ]
  • Composite efficacy outcome of full-scare trial #3 [ Time Frame: 2.5 years ]
  • Composite efficacy outcome of full-scare trial #4 [ Time Frame: 2.5 years ]
  • Composite efficacy outcome of full-scare trial #5 [ Time Frame: 2.5 years ]
  • Composite efficacy outcome of full-scare trial #6 [ Time Frame: 2.5 years ]
  • Composite efficacy outcome of full-scare trial #7 [ Time Frame: 2.5 years ]
  • Composite efficacy outcome of full-scare trial #8 [ Time Frame: 2.5 years ]

Central Contacts and Locations

Central contacts

Judy Sleek, BSc.

437-676-2974judy.sleek@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Judy Sleek, BSc

437-676-2974judy.sleek@uhn.ca

Megha Parashar, MS

Megha.Parashar2@uhn.ca

Principal Investigator:

Yasbanoo Moayedi

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 13, 2026

Last verified

Jun, 2026

Keywords

  • Primary Graft Dysfunction
  • Transplant
  • Traferox
  • Preservation Therapy
  • X Port Preservation System

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-07-13.