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Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients
Sponsor: Xenios AG
Summary
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
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)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2025-09
Completion Date
2026-09
Last Updated
2025-03-14
Healthy Volunteers
No
Interventions
Synchronized Cardiac Support with the icor kit
Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS).
Locations (2)
Krankenhaus Buchholz und Winsen gGmbH
Buchholz, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, Germany