A Prospective Single Center Study to Evaluate Safety and Efficacy of the EUROSETS Extracorporeal Membrane Oxygenation ECMOLIFE SYSTEM in Clinical Extracorporeal Life Support Applications

What this Trial Is About

Researchers are evaluating the safety and performance of the CE-marked EUROSETS ECMOLIFE SYSTEM in extracorporeal life support (ECLS) applications. This prospective single-center study involves 30 patients who require ECLS due to conditions like cardiogenic shock, post-cardiotomy low cardiac output syndrome, cardiac arrest, high-risk percutaneous coronary intervention, or extracorporeal cardiopulmonary resuscitation (eCPR). The study addresses the need for reliable devices to support critically ill cardiac patients, as high mortality and morbidity remain challenges despite current treatments. The study uses the EUROSETS ECMOLIFE SYSTEM, which includes an ECMOLIFE console, centrifugal pump, tubing set, oxygenator, and heater cooler. This system operates and monitors extracorporeal circulation to provide full or partial cardiac, circulatory, and pulmonary support. The device is used by trained healthcare professionals in operating rooms, catheter labs, emergency rooms, intensive care units, and during patient transport within the hospital. Participants will be monitored during their hospital stay and up to 30 days after ECLS initiation or hospital discharge. Researchers will collect data on device malfunctions, device-related complications, mortality, and adverse events. Surgical techniques and demographic factors will also be recorded. Follow-up will include outpatient visits and telephone calls to assess survival and any cardiac or cerebrovascular events, ensuring a comprehensive evaluation of the device's safety and performance.

EUROSETS ECMO Study in Clinical Extracorporeal Life Support Applications