Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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 abnormaliti