CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

Trial details

Who runs it

Shenzhen Core Medical Technology CO.,LTD.

Trial code

NCT06886113

Record updated

2025. március 20.

Original description

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 plannedRead full original descriptionShow less

Effects of CorVad Percutaneous Mechanical Circulatory Support in Patients with ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock.

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

Inclusion: 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: Shock due to mechanical complication to myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall; Severe peripheral arterial obstructive disease that would preclude Impella device placement; 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; Mental disorder or language barrier that preclude informed; Shock duration N24 hours; Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis; Severe aorta valve regurgitation/stenosis; Mechanical aortic valve prosthesis; Already established mechanical circulatory support (Impella or VA-ECMO); Left ventricular thrombus; Infective endocarditis; Subject with documented heparin induced thrombocytopenia; Life expectancy of less than 1 year due to comorbidities.

ClinicalTrials.gov NCT06886113