CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

Launched by SHENZHEN CORE MEDICAL TECHNOLOGY CO.,LTD. · Mar 14, 2025

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ClinConnect Summary

The CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial is a study that aims to find out if a new device, called the CorVad, can help patients who are experiencing cardiogenic shock after a heart attack. Cardiogenic shock is a serious condition where the heart cannot pump enough blood to meet the body’s needs, and it can lead to high rates of death. The CorVad device is designed to help by pumping blood directly from the heart to improve blood flow and support vital organs. This study will compare the standard treatment methods to treatment using the CorVad device in about 269 patients who meet specific health criteria.

To be eligible for this trial, patients must have had a heart attack with certain signs of cardiogenic shock for less than 24 hours. This includes having low blood pressure and evidence of poor blood flow. However, patients with other causes of shock or certain heart conditions will not be able to participate. Those who join the study can expect to either receive the CorVad treatment or the standard care, and the study will monitor how well each method works in improving their health. This trial is important because it may offer new hope for patients facing a difficult and often life-threatening situation.

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Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• 2. 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
• • 3. Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index \>1,6.
• Exclusion Criteria:
• • 1. Shock duration N24 hours
• • 2. Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis
• • 3. Shock due to mechanical complication to myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall.
• • 4. Severe aorta valve regurgitation/stenosis
• • 5. Severe peripheral arterial obstructive disease that would preclude Impella device placement
• • 6. Mechanical aortic valve prosthesis
• • 7. Already established mechanical circulatory support (Impella or VA-ECMO)
• • 8. Left ventricular thrombus
• • 9. Infective endocarditis
• • 10. Shock due to right ventricular failure
• • 11. 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.
• • 12. Subject with documented heparin induced thrombocytopenia.
• • 13. Life expectancy of less than 1 year due to comorbidities.
• • 14. Mental disorder or language barrier that preclude informed