EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEurosets S.r.l.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patients <18 years
Pregnant and breastfeeding women
Trial population
Thirty consecutive patients that require ECLS and who receive the EUROSETS ECMOLIFE SYSTEM will be included. As the current study is a prospective study, choice of the device is based on surgeons' preference. ECLS usually is an unplanned procedure, post-hoc informed consent will be obtained in ECLS survivors before hospital discharge. However, when a patient clearly stated in the patient file he or she does not wish to participate in any trials, this will be honored. A screening log providing detailed information on inclusion or reasons for exclusion will be kept in record.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Eurosets ECMO Life System
DeviceECMOLIFE 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. ECMOLIFE System must be used only in combination with ECMOLIFE Centrifugal Pump. ECMOLIFE 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. ECMOLIFE 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 / Intensivists (ER), Cardiologist (CathLab).
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: EUROSETS ECMOLIFE SYSTEM1 intervention
Trial outcomes
Primary outcomes
1
Rate of Device Malfunction
Rate of device malfunction of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.
Time frame
in-hospital, 30 days2
Rate of device related complications
Rate of device related complications of the EUROSETS device (ECMOLIFE console, ECMO TUBING SET, ECMO OXYGENATOR and ECMOLIFE CENTRIFUGAL PUMP, HEATER COOLER (called ECMOLIFE HC)) of total patients enrolled.
Time frame
in-hospital, 30 daysSecondary outcomes
1
Rate of Mortality
Rate of in-hospital and 30 day mortality.
Time frame
in-hospital, 30 days2
Rate of Adverse Events
Rate of in-hospital and 30 day adverse events.
Time frame
in-hospital, 30 daysSponsors and contacts
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Source ClinicalTrials.gov