RecruitingNCT05163925

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

Sponsor

Eurosets S.r.l.

Enrollment

30 participants

Start Date

Jan 10, 2022

Study Type

OBSERVATIONAL

Conditions

Extracorporeal Membrane Oxygenation Complication

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

Min Age: 18 Years

Inclusion Criteria2

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 Criteria2

Patients <18 years
Pregnant and breastfeeding women

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Interventions

DEVICEEurosets 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. 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).