Cardiac SurgeryHeart SurgeryCardiopulmonary BypassCoronary SurgeryAortic Valve SurgeryCannulationVenous CannulationArterial CannulationCoronary Surgery With Cardiopulmonary Bypass
Investigational drug(s) / intervention(s)
Eurosets Venous and Arterial CannulaControl Arterial and Venous Cannulas
Eurosets Venous and Arterial Cannula: Phase 1: Use of investigational Eurosets arterial and venous cannulas during CPB to assess safety and preliminary performance.The Arterial cannulae are designed for insertion in the ascending Aorta. For this Investigation the arterial cannula is reinforced-long curved with flange tip, 3/8" connector with luer lock, 24 Fr.The Venous Cannulae are designed to be used for vena cava and right atrium blood drainage during CPB surgery. For this Investigation the venous cannula is dual stage without connector, lighthouse tip, 32/40 Fr.
Phase 2: Use of investigational PVC arterial and venous cannulas during cardiopulmonary bypass (CPB) to confirm safety and evaluate performance compared to control group. For Investigation device: same of phase 1. For Control Group: the Arterial Cannula is EOPA (Medtronic), 24 Fr; the Venous Cannula is Two stage MC2 (Medtronic), 32/40 Fr.
Control Arterial and Venous Cannulas: Phase 2: Use of commercially available arterial and venous cannulas as comparator devices to evaluate the performance of the investigational PVC Arterial and Venous Cannulas during cardiopulmonary bypass (CPB) procedures. the control cannulas are EOPA 24Fr (Medtronic) as Arterial Cannula and Two Stage MC2 32/40Fr (Medtronic) as Venous Cannula.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Phase 1: Safety of Eurosets Arterial and Venous Cannulas — At Visit 1 (Pre and during surgical procedure), at Visit 2 (24 hours post-surgical procedure) and at Visit 3 (within 6-7 days post-surgical procedure) Number and type of adverse events over the duration of the investigation.
Phase 2: Performance of Eurosets Arterial Cannulas — Time points during CPB: 1st: pre-clamping/CPB initiation, 2nd: pre-weaning For Arterial cannula: the performance of the Eurosets Arterial Cannulacerebral oximetry (rSO2) will be monitored during CPB using near infrared spectroscopy (NIRS). Delta rSO2 (will be calculated as the percentage) (rate of decrease of rSO2 from pre-clamping) will be compared to delta rSO2 of control arterial cannula.
Phase 2: Performance of Eurosets Venous Cannulas — Time points during CPB: 1st: pre-clamping/CPB initiation (full flow), 2nd: 10 minutes post-clamping, 3rd: 30 minutes post-clamping. For Venous cannula: the performance of the Eurosets Venous Cannula, Central Venous Pressure (CVP) values will be monitored during CPB. Results will be compared to control venous cannula.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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