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NOT YET RECRUITING
NCT05106491
NA

Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

Sponsor: Xenios AG

View on ClinicalTrials.gov

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

DEVICE

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