NCT05106491

Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Xenios AG · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Cardiogenic Shock
• Extracorporeal Membrane Oxygenation
• ECLS
• VA ECMO

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-11-03
• Last updated: 2025-03-14

Locations

2 sites across 1 country: Germany