Clinical trial NCT06886113: CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial
Official title: Effects of CorVad Percutaneous Mechanical Circulatory Support in Patients with ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiogenic Shock
Keywords: Acute Myocardial Infarction
Lead sponsor: Shenzhen Core Medical Technology CO.,LTD.
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 outcomes:
measure: Death
timeFrame: up to 6 months
Secondary outcomes:
measure: MACCE
timeFrame: minimum follow-up 6 months
measure: Composite saftey
timeFrame: up to 6 months
measure: Days alive out of hospital
timeFrame: up to 6 months
Other outcomes:
measure: Hemodynamics
timeFrame: up to 7 days
measure: Hemodynamics
timeFrame: up to 7 days
measure: Hemodynamics
timeFrame: up to 7 days
measure: Renal function
timeFrame: up to 30 days
measure: Bleeding
timeFrame: up to 30 days
measure: Revascularization strategy
timeFrame: During procedure
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: