Post Market Study of the MOBYBOX Extracorporeal Cardiopulmonary Support Device for Patients with Cardiac and Respiratory Failure

What this Trial Is About

Researchers are evaluating the safety and performance of the MOBYBOX System, an extracorporeal cardiopulmonary support device, in patients experiencing cardiac, respiratory, or combined cardiorespiratory failure. The study aims to gather prospective data on how well the device works and its safety profile in real-world use for patients with severe conditions affecting heart and lung function. The MOBYBOX System is used in two configurations veno-arterial for cardiac or cardiorespiratory failure and veno-venous for severe respiratory failure. The device provides extracorporeal support to help patients whose heart or lungs are failing. The study monitors device performance every 4 hours while patients are receiving extracorporeal membrane oxygenation ECMO with the MOBYBOX system and records serious adverse events within 24 hours. Participants will be closely observed during their treatment with the device, with assessments focusing on safety by tracking serious adverse events within 24 hours and mortality within 30 days. Device performance success is also recorded regularly during treatment. The study will continue to follow patients until December 2026, collecting data relevant to the devices safety and effectiveness in supporting heart and lung function in critically ill patients.

A Post Market Surveillance Study of the Hemovent Extracorporeal Cardiopulmonary Support System:The MOBYBOX Trial