Heart Failure
Conditions
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.
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.
Interventions
Direct procurement of donor hearts from DCD donation
Sponsors
XVIVO Perfusion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Recipient Criteria: 1. Age ≥18 years 2. Signed informed consent form 3. Accepted and/or listed for heart transplantation Exclusion Recipient 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) Inclusion - Heart donor 1. Accepted as a heart donor by the transplant team based on current standard of care criteria 2. DCD Maastricht category III and euthanasia donors 3. Age ≤ 60 years old Exclusion - Heart Donor 1. Functional warm ischemia time (FWIT) \> 30 minutes. 2. Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (WLST) 3. Deviations from Donor end of life treatment protocol as defined by local standard operating procedures 4. Donor heart assessed as not transplantable by the responsible clinician at any time point during the donation or procurement procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient survival | 30 days post-transplant |
Secondary
| 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 |
Countries
Belgium, Netherlands
Contacts
PRINCIPAL_INVESTIGATORFilip Rega, MD, PhD
UZ Leuven
Outcome results
None listed