Feasibility Study of the Magenta Elevate22 Percutaneous Left Ventricular Assist Device for Treating Cardiogenic Shock Due to Left Heart Failure

What this Trial Is About

Researchers are evaluating the Magenta Elevate17 System, a percutaneous left ventricular assist device, in patients experiencing cardiogenic shock due to isolated or predominant left ventricular failure. This feasibility study aims to assess the initial safety, effectiveness, and performance of the device in this critical condition. The study is planned as a prospective, single-arm, interventional trial to better understand how this device may support patients with acute heart failure and cardiogenic shock. Participants will receive the Elevate17 System device during the study. This device is designed to assist the left ventricle in pumping blood, and it will be used in patients with cardiogenic shock lasting less than 24 hours and specific heart function criteria. The study involves device delivery, activation, and removal, with monitoring from baseline to 30 minutes of device activation to evaluate safety and performance. During the study, participants will be closely monitored for initial safety from device delivery through removal, device effectiveness during activation, and overall device performance. Assessments will include heart function via echocardiography and continuous observation of the devices impact. Participants will be followed through the treatment period, with study completion expected by February 2028. All evaluations focus on understanding how the device behaves and its effects on cardiogenic shock patients.

Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock