Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Cardiogenic Shock, Extracorporeal Membrane Oxygenation, ECLS, VA ECMO

Intervention / Treatment
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* Device: Synchronized Cardiac Support with the icor kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed and dated by study patient/legal representative and investigator/authorised physician Minimum age of 18 years Patients in cardiogenic shock Cardiogenic shock is defined as: Systolic blood pressure < 90 mmHg for at least 30 min Inotropes and/or vasopressors are needed to maintain systolic blood pressure > 90 mmHg Clinical signs of heart insufficiency with pulmonary congestion Signs of end organ hypoperfusion with at least one of the following criteria: Cold, damp skin or extremities Oliguria (≤ 30 mL/h) Serum lactate > 3.0 mmol/L Exclusion Criteria: 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 Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 30 min No flow time > 5 min Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture) Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.) Fever (Body temperature > 38.0 °C) or other evidence of sepsis Onset of cardiogenic shock > 6 h before enrolment Lactate > 16 mmol/L Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters Contra-indications for anticoagulation Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization<br>Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS). | Device: Synchronized Cardiac Support with the icor kit<br>* Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS).<br>* Other names: Synchronized Cardiac Support (icor);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiocirculatory stabilization and end-organ perfusion | measured by the Change in Lactate Level | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiocirculatory stabilization and end-organ perfusion | measured by the following parameter: Mean Arterial Pressure, Catecholamine Support, Cardiac Index, Cardiac Output and Cardiac Afterload | up to 14 days | 
| Maintain gas exchange | measured by the following parameter: Blood Gas Analysis and Mechanical Ventilation | up to 14 days | 
| Extracorporeal Life Support (ECLS) Performance | measured by the following parameter: Blood Flow, Blood Pressure, Synchronization of the patient's heartbeat, Intra-hospital transportation | up to 14 days | 
| Maintain renal function | measured by the following parameter: Fluid Balance, Renal Replacement Therapy, Creatinine and eGRF | up to 14 days | 
| Thermoregulation | measured by the the Body Temperature | up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Synchronized Cardiac Support, VA ECMO, ECLS