NCT06485596

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

Direct Procurement (DP) and Hypothermic Oxygenated Perfusion (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: XVIVO Perfusion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single-arm, multi-national, multicentre, proof-of-concept study to evaluate post-transplant outcomes after the use of direct procurement followed by a period of hypothermic oxygenated perfusion of the donor heart in DCD using the XVIVO Heart Assist Transport system. The investigation will be conducted at 4 heart transplant centres, one in Belgium and three in The Netherlands.The study will include 20 DCD heart transplant recipients and will evaluate transplant outcomes such as post-transplant complications, patient survival and graft function for a period of 6 months post-transplant. The study will not include a control group as this is a proof-of-concept study, investigating an alternative method of procurement of DCD hearts by providing additional safety and performance data. 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

• Heart Failure

Interventions

Type	Name	Description
DEVICE	XVIVO Heart Assist Transport System	Direct procurement of donor hearts from DCD donation

Timeline

• Start date: 2024-08-03
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-07-03
• Last updated: 2024-12-02

Locations

1 site across 1 country: Belgium