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

XVIVO

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: XVIVO Heart Assist Transport System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06485596

HOPE at Heart

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years
2. Signed informed consent form
3. Accepted and/or listed for heart transplantation

Exclusion criteria

1. Not able to understand the information provided during the informed consent procedure
2. Previous solid organ transplantation
3. Grown-up congenital heart disease
4. Dialysis
5. Incompatible blood group
6. Combined organ transplantation candidates
7. Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
8. Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

DCD Direct procurement

Experimental group

Description:

Direct procurement of DCD donor hearts

Treatment:

Device: XVIVO Heart Assist Transport System