NCT07230886 Prospective Reduction Of Transplant Complications Through Enhanced Preservation Therapy to Prevent Primary Graft Dysfunction
| NCT ID | NCT07230886 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Primary Graft Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-04-17 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-04-17 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Yasbanoo Moayedi, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT07230886 clinical trial?
This trial is open to participants of all sexes, aged 17 Years or older, studying Primary Graft Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07230886 currently recruiting?
Yes, NCT07230886 is actively recruiting participants. Contact the research team at judy.sleek@uhn.ca for enrollment information.
Where is the NCT07230886 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07230886 clinical trial?
NCT07230886 is sponsored by University Health Network, Toronto. The principal investigator is Yasbanoo Moayedi, MD at University Health Network, Toronto. The trial plans to enroll 50 participants.