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CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial
Sponsor: Shenzhen Core Medical Technology CO.,LTD.
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
Official title: Effects of CorVad Percutaneous Mechanical Circulatory Support in Patients with ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
269
Start Date
2025-10-01
Completion Date
2028-02-15
Last Updated
2025-03-20
Healthy Volunteers
Yes
Conditions
Interventions
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
Locations (1)
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China