European Study Evaluating the BrioVAD Left Ventricular Assist Device for Treating Severe Refractory Left Ventricular Heart Failure

What this Trial Is About

Researchers are evaluating the safety and performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who need mechanical circulatory support. This clinical investigation focuses on how well the BrioVAD System works in managing severe heart failure symptoms despite optimal medical treatments. The study is designed as a prospective, multi-center, single-group clinical trial aiming to compare the devices performance against established clinical outcomes. Participants will receive the BrioVAD System, a fully magnetically levitated, centrifugal-flow left ventricular assist device intended to provide both short-term and long-term mechanical support. The device is implanted in the chest and can be used inside and outside the hospital. The study evaluates the devices ability to improve survival without needing device replacement or removal due to malfunction, with a primary outcome measured at six months after implantation. During the study, participants will undergo assessments to monitor their health status and device performance. Researchers will track survival rates and any device-related complications over six months on device support. The study will continue through to 2029, with participants closely monitored to evaluate clinical benefit and safety of the BrioVAD System as a treatment for advanced heart failure.

European Study of the BrioVAD Heart Pump for Advanced Heart Failure