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.
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Phase 1: Safety of Eurosets Arterial and Venous Cannulas
Timeframe: 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)
Phase 2: Performance of Eurosets Arterial Cannulas
Timeframe: Time points during CPB: 1st: pre-clamping/CPB initiation, 2nd: pre-weaning
Phase 2: Performance of Eurosets Venous Cannulas
Timeframe: Time points during CPB: 1st: pre-clamping/CPB initiation (full flow), 2nd: 10 minutes post-clamping, 3rd: 30 minutes post-clamping.