EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications
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 applicatio
| Condition(s) | Extracorporeal Membrane Oxygenation Complication |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 info |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Eurosets S.r.l. |
| Locations | Vienna, Austria |
| Start date | 2022-01-10 |
| NCT ID | NCT05163925 |
| Official listing | https://clinicaltrials.gov/study/NCT05163925 |