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HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.

NCT06485596 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-21

No results posted yet for this study

Summary

The purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport System. Thereby increasing the utilization of DCD donor hearts in donation after circulatory death.

The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.

The secondary objectives are to evaluate patient outcomes and graft function post-transplant.

Conditions

Interventions

DEVICE

XVIVO Heart Assist Transport System

Direct procurement of donor hearts from DCD donation

Sponsors & Collaborators

  • XVIVO Perfusion

    lead INDUSTRY

Principal Investigators

  • Filip Rega, MD, PhD · UZ Leuven

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-03
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485596 on ClinicalTrials.gov