Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorXenios AG
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
Minimum age of 18 years
Patients in cardiogenic shock
Systolic blood pressure < 90 mmHg for at least 30 min
Disqualifiers
In case of female patients: pregnancy or lactation period
Participation in an interventional clinical study during the preceding 30 days
Previous participation in the same study
Age > 85 years
Trial design
Design model
Single group
Treatments tested in this trial
Synchronized Cardiac Support with the icor kit
DevicePatients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS).
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilizationOther 1 intervention
Trial outcomes
Primary outcomes
1
Cardiocirculatory stabilization and end-organ perfusion
measured by the Change in Lactate Level
Time frame
up to 14 daysSecondary outcomes
1
Cardiocirculatory stabilization and end-organ perfusion
measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload
Time frame
up to 14 days2
Maintain gas exchange
measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation
Time frame
up to 14 days3
Extracorporeal Life Support (ECLS) Performance
measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation
Time frame
up to 14 days4
Maintain renal function
measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF
Time frame
up to 14 daysOther outcomes
1
Safety Variables
1. Severe adverse events, i.e. Hemolysis Bleeding 2. Severe adverse device events
Time frame
up to 14 days Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: