Actively Recruiting
EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications
Led by Eurosets S.r.l. · Updated on 2025-07-02
30
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- VA-ECLS treatment using the EUROSETS ECMOLIFE SYSTEM (including cardiogenic shock, post cardiotomy low cardiac output syndrome, cardiac arrest, high-risk percutaneous coronary intervention, eCPR)
You will not qualify if you...
- Patients younger than 18 years
- Pregnant and breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna, Department of Cardiac Surgery
Vienna, Austria, 1090
Actively Recruiting
Research Team
A
Antonio Petralia, Dott.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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