This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety. Phase 2 is a pivotal study aimed at confirming safety and evaluating efficacy through comparison with Medtronic cannulas (control group).
The results will be compared for non-inferiority with those obtained using the control group cannulas.
Patient is considered able and willing to provide written informed consent according to the ethically approved informed consent form;
Female and male patients aged ≥ 18;
Body weight between 60 and 120 kg;
Body surface area (BSA) between 1.5 and 2.5 m2;
Emergency cases;
Re-do cardiac surgery procedure;
Diabetes mellitus;
Hematologic diseases or history of thrombophilia;