Study Evaluating the Safety and Effectiveness of the Corheart 6 Left Ventricular Assist System for Treating Advanced Left Ventricular Heart Failure in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Corheart 6 Left Ventricular Assist System LVAS for treating advanced left ventricular heart failure in adults aged 18 to 75 years. The study focuses on a European population and aims to assess the devices impact six months after implantation, with additional observation of long-term safety and effectiveness. Participants will receive the Corheart 6 LVAS device implanted to support heart function mechanically. This is a single-arm study where all enrolled patients receive the device. The study includes monitoring at various time points up to five years post-implantation to evaluate ongoing outcomes and safety. During the study, participants will be regularly assessed for survival, quality of life, and functional status using tools like the Kansas City Cardiomyopathy Questionnaire, EuroQoL-5D-5L, Six Minute Walk Test, and New York Heart Association Classification. Researchers will also monitor adverse events throughout the study duration. The primary outcome focuses on survival up to six months after implantation, with extended follow-up continuing for five years.

Corheart 6 LVAS Study