About this trial
Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. An alternative to current management is restoration of the volume of blood pumped by the heart (cardiac output) using a ventricular assist device. In the acute setting this is difficult but can be done using the CorVad device which is a catheter-based, axial flow pump that pumps blood directly from the left ventricle into the circulation thereby restoring blood flow to the failing organs. The hypothesis of the current study is to reduce mortality and morbidity of patients with cardiogenic shock using the CorVad device. The study will be carried out as a randomized multicenter study where eligible patients will be randomized to receive conventional circulatory support or support with the CorVad device and inotropic support if needed. A total of 269 patients are planned
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index >1,6.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Conventional circulatory support
DeviceControl group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs
CorVad
DeviceControl group treated with Impella CP for a minimum of 48 hrs
Treatment groups
Trial outcomes
Primary outcomes
Death
Death from all causes
Secondary outcomes
MACCE
Major cardiovascular and cerebrovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure
Composite saftey
Rate of major bleeding, vascular complications, and significant hemolysis
Days alive out of hospital
Days alive and out of hospital, calculated by subtracting the number of days spent in hospital, from time of randomization to end of follow-up (180 days) for each patient
Other outcomes
Hemodynamics
Cardiac power index
Hemodynamics
Lactate clearence
Hemodynamics
Pulmonary artery pulsatility index
Renal function
Number of Participants with acute kidney injury or need for dialysis
Sponsors and contacts
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