CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial
China269 participantsStarted 2025-10-01
Plain-language summary
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
Who can participate
Age range18 Years – 80 Years
SexALL
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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:
✓. 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