Clinical trials

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.

This is a prospective single-center study designed for evaluation of safety and performance of the Conformitè Europëenne (CE)-marked EUROSETS ECMOLIFE SYSTEM, composed by: ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC) in all clinical ECLS applications (e.g. post-cardiotomy ECLS as well as application for cardiogenic shock after myocardial infarction or resulting from other etiologies, as well as ECLS application in patients under cardiopulmonary resuscitation (eCPR) and protected PCI) in 30 consecutive patients. All demographic and perioperative variables (ECMOLIFE SYSTEM -related and unrelated ECLS complications, performances of the ECMOLIFE SYSTEM) will be analyzed. Surgical techniques will be recorded. Follow-up information on survival and any adverse cardiac and cerebrovascular events will be gathered routinely by outpatient clinic and telephone calls until 30 days after ECLS initiation or hospital discharge.