NCT06485596Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 25 Jun 2024
- Start date
- 3 Aug 2024
- Primary completion date
- Aug 2026
- Lead sponsor
- XVIVO Perfusion
- Diseases
- Heart failure
- NCT number
- NCT06485596
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 3 Aug 2024 to the primary completion date, Aug 2026
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion Recipient Criteria:
- Age ≥18 years
- Signed informed consent form
- Accepted and/or listed for heart transplantation
- Exclusion Recipient Criteria:
- 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)
- Inclusion - Heart donor
- Accepted as a heart donor by the transplant team based on current standard of care criteria
- DCD Maastricht category III and euthanasia donors
- Age ≤ 60 years old
- Exclusion - Heart Donor
- Functional warm ischemia time (FWIT) \> 30 minutes.
- Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (WLST)
- Deviations from Donor end of life treatment protocol as defined by local standard operating procedures
- Donor heart assessed as not transplantable by the responsible clinician at any time point during the donation or procurement procedure
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| UMC Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.