Evaluation of the EUROSETS ECMOLIFE SYSTEM for Extracorporeal Life Support
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
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eurosets S.r.l. Industry-sponsored |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05163925 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients under 18 years old, as well as pregnant or breastfeeding women, will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vienna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.