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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: XVIVO Heart Assist Transport System

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 40 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCD Direct procurement; Direct procurement of DCD donor hearts	Device: XVIVO Heart Assist Transport System; Direct procurement of donor hearts from DCD donation; Other Names: Direct procurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient survival	30 days post-transplant

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiac related mortality	30 days post-transplant
Incidence of Mechanical circulatory support	30 days post-transplant
Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant (Kobashigawa et al., 2014)	30 days post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant	30 days post-transplant
Incidence of perfused hearts which are not used for transplantation	30 days post-transplant
Total duration of ICU stay (days)	30 days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)	30 days post-transplant
Cardiac related mortality at 6 months post-transplant	6 months post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF)	6 months post-transplant
Number of days until hospital discharge from index procedure	30 days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)	6 months post-transplant

Collaborators and Investigators

• Sponsor: XVIVO Perfusion
• Investigators: Principal Investigator: Filip Rega, MD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: HOPE at Heart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No