Cardiogenic Shock Clinical Trial
Official title:
Evaluating the Efficacy and Safety of the Synchronized Cardiac Support Treatment With the Icor Kit in Patients With Cardiogenic Shock - a Pivotal Study (Pulse SE)
The study aims to investigate the safety and efficacy of the Synchronized Cardiac Support treatment wit the icor kit and the Xenios console with modified sensor box ECG and Software Version 3.2.4
The current study hypothesizes that The SCS treatment with the icor kit provides sufficient support for cardiocirculatory function as indicated by a significant lactate reduction 24 hours on SCS treatment versus before treatment start. Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support. Synchronized Cardiac Support describes an electrocardiogram (ECG)- triggered pulsatile VA-ECMO based on R-wave detection. During diastole the pump speed and thus the flow is increased and during systole the pump flow is been set on a relative minimum. This provides a mechanical circulatory support pulse with oxygenated blood during diastole. The Synchronized Cardiac Support Treatment is used in a standard VA ECMO configuration by two femoral single vessel cannulas. Patients following cardiac resuscitation will undergo targeted temperature management 32- 36°C according to guideline. The Duration of Treatment can be up to 14 days. ;
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