CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial

NCT06886113 | Not Yet Recruiting

• 1 other identifier: COREMED_Corvad_AMICS
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiogenic Shock

Keywords

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Death

  Death from all causes

  up to 6 months

Secondary Outcomes (3)

• MACCE

  minimum follow-up 6 months

• Composite saftey

  up to 6 months

• Days alive out of hospital

  up to 6 months

Other Outcomes (6)

• Hemodynamics

  up to 7 days

• Hemodynamics

  up to 7 days

• Hemodynamics

  up to 7 days

Study Arms (2)

Conventional circulatory support

PLACEBO COMPARATOR

Patients randomized to conventional circulatory support

Device: Conventional circulatory support

CorVad

ACTIVE COMPARATOR

Patients randomized to CorVad

Device: CorVad

Interventions

Conventional circulatory support DEVICE

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

Conventional circulatory support

CorVad DEVICE

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

CorVad

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Severe peripheral arterial obstructive disease that would preclude Impella device placement
• Mechanical aortic valve prosthesis
• Already established mechanical circulatory support (Impella or VA-ECMO)
• Left ventricular thrombus
• Infective endocarditis
• Shock due to right ventricular failure
• Subject with documented heparin induced thrombocytopenia.
• Life expectancy of less than 1 year due to comorbidities.
• Mental disorder or language barrier that preclude informed

Sponsors & Collaborators

• Shenzhen Core Medical Technology CO.,LTD.: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

Xiaoli Shi VP

CONTACT

+86 13418601356; shixiaoli@coretechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 15, 2028
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

CN (1)