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;
Sequential
Eurosets Venous and Arterial Cannula
DevicePhase 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
DevicePhase 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.
Phase 1: Safety of Eurosets Arterial and Venous Cannulas
Number and type of adverse events over the duration of the investigation.
Phase 2: Performance of Eurosets Arterial Cannulas
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
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.
Phase 1: Clinical Parameters collected for safety: pH
Clinical parameters monitored with pH value
Phase 1: Clinical Parameters collected for safety: pCO2
Clinical parameters: pCO2 recorded with mmHg
Phase 1: Clinical Parameters collected for safety: pO2
Clinical parameters: pO2 recorded with mmHg
Phase 1: Clinical Parameters collected for safety: Blood Flow
Clinical parameters: Blood flow recorded with L/min
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pH
Clinical parameters monitored with pH value
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pCO2
Clinical parameters: pCO2 recorded with mmHg
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pO2
Clinical parameters: pO2 recorded with mmHg
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Bloof flow
Clinical parameters: Blood flow recorded with L/min
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