Cardiogenic ShockCorvad AMICSNCT06886113
CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial
A study testing Conventional circulatory support and CorVad in people with Cardiogenic Shock, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Conventional circulatory support and CorVad
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 269 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 15 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- Already established mechanical circulatory support (Impella or VA-ECMO)
- Left ventricular thrombus
- Infective endocarditis
- Shock due to right ventricular failure
- 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.
- Subject with documented heparin induced thrombocytopenia.
- Life expectancy of less than 1 year due to comorbidities.
- Mental disorder or language barrier that preclude informed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jun Jiang, +86 13588706891, drjayj@hotmail.com
About this study
Official title: Effects of CorVad Percutaneous Mechanical Circulatory Support in Patients with ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock.
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
Read the 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
- Being tested
- Conventional circulatory support, CorVad
- Keywords
- Acute Myocardial Infarction
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional circulatory supportDevice
Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs
CorVadDevice
Control group treated with Impella CP for a minimum of 48 hrs
| Study group | Role | What they receive |
|---|---|---|
| Conventional circulatory support | Placebo comparator | Patients randomized to conventional circulatory support Receives: Device: Conventional circulatory support |
| CorVad | Active comparator | Patients randomized to CorVad Receives: Device: CorVad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death from all causes
Measured: up to 6 months
Secondary outcomes (3)
MACCE
Major cardiovascular and cerebrovascular events, death, cardiac transplant, escalation to permanent left ventricular assist device, re-hospitalization for heart failure
Measured: minimum follow-up 6 months
Composite saftey
Rate of major bleeding, vascular complications, and significant hemolysis
Measured: up to 6 months
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
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886113
- Sponsor's protocol ID
- COREMED_Corvad_AMICS
- Acronym
- Corvad AMICS
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CorVad Percutaneous Mechanical Circulatory Support in Patients with ST Segment Elevation Myocardial Infarction Complicated by Cardiogenic Shock.
- ClinicalTrials.gov ID
- NCT06886113
- Acronym / sponsor ID
- Corvad AMICS / COREMED_Corvad_AMICS
- Conditions
- Cardiogenic Shock
- Keywords
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Shenzhen Core Medical Technology CO.,LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional circulatory support | Placebo comparator | Device: Conventional circulatory supportPatients randomized to conventional circulatory support |
| CorVad | Active comparator | Device: CorVadPatients randomized to CorVad |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional circulatory supportControl group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs | Device | Conventional circulatory support |
| CorVadControl group treated with Impella CP for a minimum of 48 hrs | Device | CorVad |
Primary outcome
Death
Time frame: up to 6 months
Death from all causes
3 secondary outcomes
MACCE
Time frame: minimum follow-up 6 months
Composite saftey
Time frame: up to 6 months
Days alive out of hospital
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional circulatory support and CorVad in people with Cardiogenic Shock, run by Shenzhen Core Medical Technology CO.,LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Shi VP (+86 13418601356, shixiaoli@coretechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.