Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients (NCT05106491) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients
Germany21 participantsStarted 2025-09
Plain-language 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
Who can participate
Age range18 Years ā 85 Years
SexALL
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Inclusion criteria
ā. Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
ā. Minimum age of 18 years
ā. Patients in cardiogenic shock
ā. Cardiogenic shock is defined as:
ā. Systolic blood pressure \< 90 mmHg for at least 30 min
ā. Inotropes and/or vasopressors are needed to maintain systolic blood pressure \> 90 mmHg
ā. Clinical signs of heart insufficiency with pulmonary congestion
ā. Signs of end organ hypoperfusion with at least one of the following criteria:
Exclusion criteria
ā. In case of female patients: pregnancy or lactation period
ā. Participation in an interventional clinical study during the preceding 30 days
ā. Previous participation in the same study
ā. Age \> 85 years
ā. Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) \> 30 min
ā. No flow time \> 5 min
What they're measuring
1
Cardiocirculatory stabilization and end-organ perfusion