EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications

Recruiting now

Conditions studied: Extracorporeal Membrane Oxygenation Complication

In brief

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.

Key facts

Study ID

NCT05163925

Run by

Eurosets S.r.l.

People needed

30

Starts

2022-01-10

Expected to finish

2025-07-01

Last updated by the study team

2025-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥18 years
• VA-ECLS application using the EUROSETS ECMOLIFE SYSTEM (e.g. cardiogenic shock, post cardiotomy low cardiac output syndrome, cardiac arrest, high risk percutaneous coronary intervention, eCPR)

You may not qualify if…

• Patients <18 years
• Pregnant and breastfeeding women

Where it is running

• Medical University of Vienna, Department of Cardiac Surgery — Vienna, Austria (enrolling)

Full record on ClinicalTrials.gov

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