CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

The study is a prospective, multicenter trial in patients with AMICS randomized 1:1 to CorVad or current guideline-driven therapy with planned enrollment of 269 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive CorVad, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days.The target population of subjects are patients with acute myocardial infarction with cardiogenic shock who need high-risk PCI treatment, and sign an informed consent form (ICF) approved by the Ethics Committee (EC). Subjects who meet the enrolment criteria as judged by the investigator will apply the trial product according to the requirements and will be followed up to 180 days after the procedure.

Inclusion criteria

• ST segment elevation myocardial infarction of less than 36 hours' duration, confirmed by new onset ST-segment elevation, or emergency angiography demonstrating acute occlusion of coronary artery, and
• Cardiogenic shock of less than 24 hours' duration, confirmed by:

peripheral signs of tissue hypoperfusion (arterial blood lactate ≥2.5mmol/l and/or SvO2 <55% with a normal PaO2) and systolic blood pressure less than 100mmHg and/or need for vasopressor therapy (dopamine/ norepinephrine or epinephrine), and

• Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index >1,6.

Exclusion criteria

• Shock duration N24 hours
• Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis
• Shock due to mechanical complication to myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall.
• Severe aorta valve regurgitation/stenosis
• Severe peripheral arterial obstructive disease that would preclude Impella device placement
• Mechanical aortic valve prosthesis
• Already established mechanical circulatory support (Impella or VA-ECMO)
• Left ventricular thrombus
• Infective endocarditis
• Shock due to right ventricular failure
• Out of hospital cardiac arrest with persistent Glasgow coma scale b8 after return of spontaneous circulation. Cardiac arrest occurring in ambulance or after arrival to hospital is not an exclusion criterion.
• Subject with documented heparin induced thrombocytopenia.
• Life expectancy of less than 1 year due to comorbidities.
• Mental disorder or language barrier that preclude informed