Evaluation of the EUROSETS ECMOLIFE SYSTEM for Extracorporeal Life Support
Official title: A Prospective Single Center Study to Evaluate Safety and Efficacy of the EUROSETS Extracorporeal Membrane Oxygenation ECMOLIFE SYSTEM in Clinical Extracorporeal Life Support Applications EUROSETS ECMO STUDY
Run by Eurosets S.r.l. · NCT05163925 · Data updated 2026-11-12
This study is testing the safety and performance of a new life support system in patients who need help with their heart and lungs due to serious conditions.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Eurosets S.r.l. Industry-sponsored |
| Locations | 1 site (Vienna) |
| Status | Recruiting |
| Started | January 10, 2022 |
| Main results expected | July 2025 |
| Study ends | July 2025 |
| Registry record updated | July 2, 2025 |
| Trial ID | NCT05163925 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are undergoing VA-ECLS using the EUROSETS ECMOLIFE SYSTEM for conditions like cardiogenic shock or cardiac arrest.
✕Probably not a fit
Patients under 18 years old, as well as pregnant or breastfeeding women, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the safety and performance of the EUROSETS ECMOLIFE SYSTEM in various clinical applications of extracorporeal life support (ECLS). It will involve 30 consecutive patients who require veno-arterial extracorporeal membrane oxygenation (VA-ECMO) due to conditions such as cardiogenic shock or post-cardiotomy low cardiac output syndrome. The study will collect demographic and perioperative data, analyze ECLS-related complications, and monitor patient outcomes, including survival and adverse events, for 30 days post-initiation of ECLS. The findings will contribute to understanding the effectiveness of this system in critical care settings.
Why it matters
Potential benefit: If successful, this study could improve patient outcomes and survival rates in critically ill patients requiring extracorporeal life support.
How similar studies have gone: While there have been studies on ECLS, this specific evaluation of the EUROSETS ECMOLIFE SYSTEM is novel and has not been extensively tested in prior research.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Medical University of Vienna, Department of Cardiac Surgery
Vienna, Austria Recruiting
Study contacts
- Study coordinator: Antonio Petralia, Dott.
- Email: apetralia@eurosets.com
- Phone: +39 0535 660370
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Safety and performance of the Novalung kit and Xenios 2.0 during stationary use for patients on ECMO
This observational study tests whether using the Novalung ultimate kit with Xenios 2.0 (and MultiSupport Ground) helps maintain blood oxygenation in adults on ECMO during hospital stay and ground transport.
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Using near apneic ventilation with ECMO for severe respiratory distress
This study is testing if a new way of breathing support called near apneic ventilation can help patients with severe respiratory distress on ECMO recover better and faster than the usual care.
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Using cangrelor to improve outcomes in patients with cardiogenic shock on ECMO
This study is testing if adding a medication called cangrelor can help patients in cardiogenic shock on ECMO have better outcomes while reducing bleeding risks during their treatment.
-
Investigating left ventricle unloading during extracorporeal life support
This study looks at how different methods of relieving pressure on the heart can help patients on a special life support system called VA ECLS, especially those in serious heart trouble.
-
MiniLung petite kit for neonates and infants with severe respiratory or cardiac failure
We will test whether the MiniLung petite kit with the Xenios console safely improves oxygenation, removes CO2, and stabilizes circulation in newborns and young infants (2–8 kg) with severe respiratory or cardiopulmonary failure.
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RECOMMEND platform testing interventions for adults receiving ECMO
This platform tests whether different treatments, such as liberal versus restrictive red blood cell transfusion strategies, help adults on ECMO survive and need less organ support and hospital resources by day 28.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.