The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial. The primary hypothesis is that the non-ischemic hypothermic cardioplegic preservation (NIHP) is safe and superior to ischemic cold static storage (ICSS) of donor hearts. The study will investigate the safety and superiority of the new methodology in terms of improved immediate and prolonged organ function in adult heart transplanted patients.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria recipient:
* Age ≥18 years
* Signed informed consent form
* Listed for heart transplantation
Inclusion criteria donor:
* Age ≥18 and ≤70 years
* Accepted as heart donor by the transplant team
* (Research consent from the donor if required in country)
Exclusion Criteria recipient:
* Previous solid organ transplantation
* Grown-up congenital heart disease (GUCH)
* Kidney failure eGFR\<40 at listing, calculated by CDK-EPI Creatinine, or ultrafiltration or dialysis or rapidly deteriorating kidney function due to a diagnosed renal disease
* Coagulopathy due to known hepatic disease or heparin induced thrombocytopenia
* Subject diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis
* Known ongoing septicemia defined as positive blood culture immediately prior to the transplant (including with a durable VAD)
* Incompatible blood group
* Not able to understand the information provided during the informed consent procedure
* Combined organ transplantation candidates
* Subject already enrolled in another transplant related intervention study
* 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)
Exclusion criteria donor:
* Previous sternotomy
* DCD hearts