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

NCT06485596 | Active Not Recruiting

• 1 other identifier: HOPE at Heart
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Patient survival

  30 days post-transplant

Secondary Outcomes (11)

• 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

Study Arms (1)

DCD Direct procurement

EXPERIMENTAL

Direct procurement of DCD donor hearts

Device: XVIVO Heart Assist Transport System

Interventions

XVIVO Heart Assist Transport System DEVICE

Direct procurement of donor hearts from DCD donation

Also known as: Direct procurement

DCD Direct procurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Signed informed consent form
• Accepted and/or listed for heart transplantation

You may not qualify if:

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

Sponsors & Collaborators

• XVIVO Perfusion: lead

Study Sites (1)

UZ Leuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Filip Rega, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 3, 2024
• Study Start: August 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)