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โ† Trials
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Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

RecruitingNAAges 18 Years - anyAllEurosets S.r.l.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • Eurosets Venous and Arterial Cannula
  • Control Arterial and Venous Cannulas
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Where

1 site
Anthea Hospital GVM Care & Research
Bari, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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