Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

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.

NCT Number	NCT07354841
Lead Sponsor	Eurosets S.r.l.
Conditions	Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery, Aortic Valve Surgery, Cannulation, Venous Cannulation, Arterial Cannulation +1 more
Enrollment	80 participants
Start Date	2025-10-21
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-21