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Clinical Trials in China / NCT06886113
Starting soon Not applicable

CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

NCT06886113 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Core Medical Technology CO.,LTD.
Phase
Not applicable
Started
2025-10-01
Last updated
2025-03-20

Condition(s) studied

Cardiogenic Shock

Investigational drug(s) / intervention(s)

Conventional circulatory supportCorVad

Conventional circulatory support: Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs

CorVad: Control group treated with Impella CP for a minimum of 48 hrs

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang

More Shenzhen Core Medical Technology CO.,LTD. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06886113 on ClinicalTrials.gov ↗ ← All trials in China