Clinical Research Directory

Inclusion Criteria: 1. Patient is considered able and willing to provide written informed consent according to the ethically approved informed consent form; 2. Female and male patients aged ≥ 18; 3. Body weight between 60 and 120 kg; 4. Body surface area (BSA) between 1.5 and 2.5 m2; 5. Patients scheduled to undergo central cannulation for cardiopulmonary bypass (CPB) in elective surgery procedures (isolated coronary and/or aortic valve surgery). Exclusion Criteria: 1. Emergency cases; 2. Re-do cardiac surgery procedure; 3. Diabetes mellitus; 4. Hematologic diseases or history of thrombophilia; 5. Pregnancy or breastfeeding; 6. Concomitant major cardiac procedures; 7. Active malignant/metastatic neoplasm of any type; 8. Presence of pneumothorax and/or pulmonary emphysema; 9. Significant central nervous system injury; 10. Current intracranial hemorrhage; 11. Immunosuppression; 12. Contraindication for therapeutic anticoagulation (e.g., heparin); 13. Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study; 14. Abnormal or pathological cannulation site; 15. Uncontrolled active bleeding; 16. Awaiting transplantation; 17. Requiring preoperative extracorporeal membrane oxygenation; 18. Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the Investigator may interfere with the participation to the study. 19. Patient is taking part in another interventional clinical study; 20. Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.