NCT05163925 EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications
| NCT ID | NCT05163925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eurosets S.r.l. |
| Condition | Extracorporeal Membrane Oxygenation Complication |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-01-10 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2022-01-10 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Antonio Petralia, Dott.
STUDY DIRECTOR
Eurosets S.r.l.
Frequently Asked Questions
Who can join the NCT05163925 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Extracorporeal Membrane Oxygenation Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05163925 currently recruiting?
Yes, NCT05163925 is actively recruiting participants. Contact the research team at apetralia@eurosets.com for enrollment information.
Where is the NCT05163925 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT05163925 clinical trial?
NCT05163925 is sponsored by Eurosets S.r.l.. The principal investigator is Antonio Petralia, Dott. at Eurosets S.r.l.. The trial plans to enroll 30 participants.