NCT07354841 Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
| NCT ID | NCT07354841 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eurosets S.r.l. |
| Condition | Cardiac Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-10-21 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07354841 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07354841 currently recruiting?
Yes, NCT07354841 is actively recruiting participants. Contact the research team at gnasso@libero.it for enrollment information.
Where is the NCT07354841 trial being conducted?
This trial is being conducted at Bari, Italy.
Who is sponsoring the NCT07354841 clinical trial?
NCT07354841 is sponsored by Eurosets S.r.l.. The trial plans to enroll 80 participants.