Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
Trial Parameters
Brief Summary
The Elevate™ CS Clinical Feasibility Study is designed to evaluate the initial safety, effectiveness, and device performance of the Magenta Elevate™ System in patients with cardiogenic shock due to isolated or predominant left ventricular failure.
Eligibility Criteria
Inclusion Criteria: * Cardiogenic shock of less than 24 hours duration. * Left ventricular ejection fraction \< 45% and \> 15%, as determined by echocardiography on the day of inclusion. * No more than mild right ventricular dysfunction, as determined by echocardiography on the day of inclusion. * Signed informed consent. Exclusion Criteria: * Other causes of shock: hypovolemia, sepsis (any active systemic infection including acute myocarditis), pulmonary embolism or anaphylaxis. * Patient with oxygen saturation \< 90% (pulse oximeter/arterial) at the planned time of device placement (uncorrected by oxygen supplementation or intubation). * Sustained VT (at the time of the enrollment). * Significant right heart failure/right ventricular dysfunction. * Awake patient who is unable to remain in a stable recumbent position due to restlessness or lack of cooperation for other reasons. * Hypertrophic obstructive cardiomyopathy. * Left ventricular thrombus. * Subjects with a placed IABP. * Mit