CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShenzhen Core Medical Technology CO.,LTD.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Left ventricular ejection fraction of less than 45% visually estimated or by wall motion score index >1,6.

Disqualifiers

Shock duration N24 hours

Other causes of shock; hypovolemia, sepsis, pulmonary embolism or anaphylaxis

Shock due to mechanical complication to myocardial infarction; papillary muscle rupture, rupture of the ventricular septum or rupture of ventricular free wall.

Severe aorta valve regurgitation/stenosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional circulatory support

    Device

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

  • CorVad

    Device

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

Treatment groups

269 Participants
are divided into 2 treatment groups
Group A: Conventional circulatory supportPlacebo comparator 1 intervention
Group B: CorVadActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Death

Death from all causes

Time frame
up to 6 months

Secondary outcomes

1

MACCE

Major cardiovascular and cerebrovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure

Time frame
minimum follow-up 6 months
2

Composite saftey

Rate of major bleeding, vascular complications, and significant hemolysis

Time frame
up to 6 months
3

Days alive out of hospital

Days alive and out of hospital, calculated by subtracting the number of days spent in hospital, from time of randomization to end of follow-up (180 days) for each patient

Time frame
up to 6 months

Other outcomes

1

Hemodynamics

Cardiac power index

Time frame
up to 7 days
2

Hemodynamics

Lactate clearence

Time frame
up to 7 days
3

Hemodynamics

Pulmonary artery pulsatility index

Time frame
up to 7 days
4

Renal function

Number of Participants with acute kidney injury or need for dialysis

Time frame
up to 30 days

Sponsors and contacts

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