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NOT YET RECRUITING
NCT06886113
NA

CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

Sponsor: Shenzhen Core Medical Technology CO.,LTD.

View on ClinicalTrials.gov

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

Interventions

DEVICE

Conventional circulatory support

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

DEVICE

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