End-stage heart failure
Conditions
Interventions
Heart transplantation.
Sponsors
XVIVO Perfusion AB
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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 =18 years 2. Signed informed consent form 3. Accepted or listed for heart transplantation
Exclusion criteria
Exclusion criteria: 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 Exclusion Recipient 1. Not able to understand the information provided during the informed consent procedure 2. Previous solid organ transplantation 3. Grown-up congenital heart disease (GUCH) 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 at time of transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as patient survival at 30 days post-transplant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints at 30-days post-transplant 1. Cardiac related mortality at 30 days post-transplant 2. Incidence of Mechanical circulatory support within 30 days post-transplant 3. Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant (Kobashigawa et al., 2014) 4. Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant 5. Incidence of hearts perfused on the investigational device which are not used for transplantation 6. Total duration of ICU stay (days) 7. Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime) within 30 days post-transplant Secondary endpoints at 6 months post-transplant 8. Cardiac related mortality at 6 months post -transplant 9. Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 6 months post-transplant 10. Number of days until hospital discharge from index procedure 11. Incidence of biopsy proven rejections > 1 ACR leading to changed immunosuppressive regime within 6 months post-transplant Exploratory endpoints 12. Cardiac biopsy collected before reperfusion (optional and only if in clinical routine) | — |
Countries
Belgium, Netherlands
Contacts
Public ContactAW Wallinder
XVIVO Perfusion AB
Outcome results
None listed