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RECRUITING
NCT07556588
NA

XVIVO Heart Transplant Study in Clinical Practice

Sponsor: XVIVO Perfusion

View on ClinicalTrials.gov

Summary

HOPE for All is a clinical investigation to support the use of hypothermic oxygenated perfusion (HOPE) using a revised XVIVO Heart Assist Transport System in a real- world setting. The trial will investigate the application of HOPE in a broad population of Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donor hearts transplanted to any listed adult patient. The hypothesis is that the use of HOPE is safe and feasible for any adult patient awaiting a heart transplantation. Primary objective is to evaluate patient survival in the real world setting after heart transplantation, where HOPE using the revised XVIVO Heart Assist Transport System is used for donor heart preservation. Secondary objective(s) are to evaluate patient outcomes and graft function post-transplant. HOPE for All is a prospective, single-armed single-centre proof-of-consept trial.

Official title: Application of Hypothermic Oxygenated Perfusion in Donor Heart Preservation in Clinical Practice - HOPE for All

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-08-03

Completion Date

2028-04-15

Last Updated

2026-08-12

Healthy Volunteers

No

Conditions

Interventions

DEVICE

XVIVO Heart Assist Transport System

Revised XHAT

Locations (1)

UZ Leuven

Leuven, Belgium