Using a new system to improve heart transplants from donors after circulatory death
Direct Procurement (DP) and Hypothermic Oxygenated Perfusion (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System
This study is testing a new system to see if it can help improve heart transplants from donors who have died by circulatory death, focusing on how well the transplanted hearts work for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | XVIVO Perfusion Industry-sponsored |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06485596 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to enhance the utilization of donor hearts from individuals who have experienced circulatory death by employing the XVIVO Heart Assist Transport System for hypothermic oxygenated perfusion. The study is a prospective, single-arm, multi-national, multicentre proof-of-concept initiative that will evaluate the survival and outcomes of 20 heart transplant recipients over a six-month period. By directly procuring these hearts and utilizing advanced preservation techniques, the study seeks to provide critical data on patient survival and graft function post-transplant. The research will be conducted across four heart transplant centers in Belgium and the Netherlands.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are accepted or listed for heart transplantation.
Not a fit: Patients who have previously undergone solid organ transplantation or have specific contraindications such as dialysis or incompatible blood groups may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the availability of donor hearts for transplantation, improving outcomes for patients with heart failure.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel investigation in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Filip Rega, MD, PhD — UZ Leuven
- Study coordinator: Marina Fredholm, MSc
- Email: marina.fredholm@xvivogroup.com
- Phone: +46 733 929 502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.