[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451855":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Eurosets S.r.l.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EUROSETS ECMOLIFE SYSTEM",null,"Thirty consecutive patients that require ECLS and who receive the EUROSETS ECMOLIFE SYSTEM will be included. ECMOLIFE System is a perfusion system enabling operation and monitoring of extracorporeal circulation. ECMOLIFE System operates, powers, controls and regulates ECMOLIFE Centrifugal Pump which represents the disposable blood pump. ECMOLIFE System, when used in combination with ECMOLIFE Centrifugal Pump, is suitable for full or partial cardiac, circulatory and pulmonary support.\n\nECMOLIFE System is composed by an active programmable console (ECMOLIFE Console), a bearing-less motor driver (ECMOLIFE Motor driver), and sensors for blood parameters detection (flow rate, pressure, temperature, SvO2 and Hb). The console is equipped with an integrated back-up which in case of primary unit failure may be operated in combination with a back-up motor driver and flowmeter (besides, the ECMOLIFE system includes an Heater cooler device).",[13],"Device: Eurosets ECMO Life System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Eurosets ECMO Life System","ECMOLIFE System in combination with ECMOLIFE Centrifugal Pump and ECC (extra-corporeal-circulation) Tubing Set is intended to pump blood through the extracorporeal circuit to provide extracorporeal circulation.\n\nECMOLIFE System must be used only in combination with ECMOLIFE Centrifugal Pump.\n\nECMOLIFE System is intended to operate in the following hospital environments: Operating Room, Catheter Laboratory, Emergency Room, Intensive Care Unit and during intra-hospital patient transportation from one to another Unit.\n\nECMOLIFE System is intended to be used by qualified healthcare professionals specifically trained in the field of extracorporeal circulation: Perfusionists (Thoracic Cardiovascular Surgery - OR), Intensivists, ICU Nurses (ICU), Emergency physicians \u002F Intensivists (ER), Cardiologist (CathLab).",[9],[21],{"name":22,"affiliation":5,"role":23},"Antonio Petralia, Dott.","STUDY_DIRECTOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+39 0535 660370","apetralia@eurosets.com",[30],{"facility":31,"status":32,"city":33,"state":10,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Medical University of Vienna, Department of Cardiac Surgery","RECRUITING","Vienna","1090","Austria","AT",{"type":38,"coordinates":39},"Point",[40,41],16.37208,48.20849,{"lat":41,"lon":40},[44,49],{"name":45,"role":26,"phone":46,"phoneExt":47,"email":48},"Julia Riebandt, PD DDr.","+43 (1) 40400","69700","julia.riebandt@meduniwien.ac.at",{"name":45,"role":50,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100451855","eurosets-ecmo-study-in-clinical-extracorporeal-life-support-applications-100451855",false,"NCT05163925","EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications","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","Inclusion Criteria:\n\n* Patients ≥18 years\n* 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)\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years\n* Pregnant and breastfeeding women","ALL","18 Years",{"count":63,"type":64},30,"ESTIMATED","OBSERVATIONAL","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.\n\nAll 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.",[68],"Extracorporeal Membrane Oxygenation Complication",[70],"Extracorporeal Life Support Applications","2025-07-01",{"date":73,"type":74},"2025-07-02","ACTUAL",{"date":76,"type":74},"2022-01-10",{"date":78,"type":64},"2025-07",{"name":5,"class":6},1]