EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications

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.

NCT Number	NCT05163925
Lead Sponsor	Eurosets S.r.l.
Conditions	Extracorporeal Membrane Oxygenation Complication
Enrollment	30 participants
Start Date	2022-01-10
Primary Completion	2025-07 (estimated)
Study Completion	2025-07 (estimated)
Updated on ClinicalTrials.gov	2025-07-02