NCT06886113

CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 269 (estimated)
• Sponsor: Shenzhen Core Medical Technology CO.,LTD. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Detailed description

The study is a prospective, multicenter trial in patients with AMICS randomized 1:1 to CorVad or current guideline-driven therapy with planned enrollment of 269 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive CorVad, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days.The target population of subjects are patients with acute myocardial infarction with cardiogenic shock who need high-risk PCI treatment, and sign an informed consent form (ICF) approved by the Ethics Committee (EC). Subjects who meet the enrolment criteria as judged by the investigator will apply the trial product according to the requirements and will be followed up to 180 days after the procedure.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-08-31
• Completion: 2028-02-15
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

1 site across 1 country: China