Synchronized Cardiac Assist for Cardiogenic Shock

Study Overview
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Brief Summary
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The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.

Official Title
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Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial

Conditions
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Shock, Cardiogenic, High Risk Percutaneous Coronary Interventions

Intervention / Treatment
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* Device: i-cor Synchronized Cardiac Assist Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in cardiogenic shock in the setting of acute myocardial infarction or Patients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, left main, or last patent conduit interventions) in the catheterization lab. Cardiogenic shock is defined as Systolic blood pressure < 90 mmHg for at least 30 min or Inotropes are needed to maintain blood pressure > 90 mmHg or Clinical signs of heart insufficiency with pulmonary congestion or Signs of end organ hypoperfusion with at least one of the following criteria: Altered mental status cold, damp skin or extremities oliguria (≤ 30 mL/h) serum lactate > 2.0 mmol/L Written consent of the patient or the legal caregiver - Exclusion Criteria: Age > 85 years Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 10 min Coma with fixed pupils not induced by drugs; 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 enrollment; Lactate > 22 mmol/L; Massive pulmonary embolism; Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters Previous known aortic regurgitation greater than grade II Contra-indications for anticoagulation Severe hemolysis of any cause Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: i-cor Synchronized Cardiac Assist Device|The i-cor Synchronized Cardiac Assist Device delivers pulsatile cardiac assist synchronized to the ECG during diastole and provides enhanced oxygenation through a membrane oxygenator.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Device and Procedure Related Serious Adverse Events | Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention. | 30 days | 
| Number of Participants Treated With Technical Success of the Device | Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events). | 24 hours | 
| Number of Participants With Device Performance Success | Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient. | 7 days |