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EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications

Recruitingn/aAges 18 Years - anyAllEurosets S.r.l.
NCT05163925 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 b

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * Patients \<18 years * Pregnant and breastfeeding women
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What it tests

  • Eurosets ECMO Life System
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Where

1 site
Medical University of Vienna, Department of Cardiac Surgery
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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