An interventional study of Conventional circulatory support and CorVad in Cardiogenic Shock, sponsored by Shenzhen Core Medical Technology CO.,LTD.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Shenzhen Core Medical Technology CO.,LTD. · Not applicable, Interventional, and Treatment
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Among 20 studies in Shock, Cardiogenic with a site in China — 18 open to participants now, 18 under way, none of them phase 3. Shock, Cardiogenic · China.
Among the 20 studies in Shock, Cardiogenic with a site in China, this one is the 4th largest by planned enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2025, is one of 12 with no phase, reaches primary completion later than 10 of the 17 other live ones, and was the 15th registered.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
Browse Shock, Cardiogenic studies →18 of the 20 studies in Shock, Cardiogenic with a site in China are open now. Recruiting first, the newest first:
ForQaly Medical (Shanghai) Co., Ltd · Sites in China
Ages 18–80
China National Center for Cardiovascular Diseases · Sites in China
Ages 18+
Renmin Hospital of Wuhan University · Sites in China
Ages 18+
Xiaotong Hou · Sites in China
Ages 18+
Shenzhen Core Medical Technology CO.,LTD. · Sites in China
Ages 18–80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 102 Shock, Cardiogenic studies recruiting now, 70 (69%) set no upper age limit and 9 (9%) stop at 75 or younger; 11 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · healthy volunteers too.
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20 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 269 is above the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Median enrollment 82 across the 14 interventional studies, 517 across the 6 observational. Of the 1 that completed or were terminated, 0 (0%) have results posted.
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3 of 20 have an industry lead sponsor. The 10 most frequent:
Shenzhen Core Medical Technology CO.,LTD. is the lead sponsor of 12 studies on the registry; 8 are open to participants now.
Shenzhen Core Medical Technology CO.,LTD. has 2 studies filed under Shock, Cardiogenic — fewer than ten, so there is no comparison to draw.
3 of the studies in Shock, Cardiogenic with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06862700Xiaotong HouEffect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients | 2027-01-01 |
| NCT07380659Second Affiliated Hospital, School of Medicine, Zhejiang UniversitySafety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock | 2027-01-30 |
| NCT07560085ForQaly Medical (Shanghai) Co., LtdCatheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock | 2027-06 |
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Among the 20 studies in Shock, Cardiogenic with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to conventional circulatory support
Device: Conventional circulatory support
Patients randomized to CorVad
Device: CorVad
Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs
Control group treated with Impella CP for a minimum of 48 hrs
Death
Death from all causes
Time frame: up to 6 months
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
Composite saftey
Rate of major bleeding, vascular complications, and significant hemolysis
Time frame: 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
Time frame: up to 6 months
Hemodynamics
Cardiac power index
Time frame: up to 7 days
Hemodynamics
Lactate clearence
Time frame: up to 7 days
Hemodynamics
Pulmonary artery pulsatility index
Time frame: up to 7 days
Renal function
Number of Participants with acute kidney injury or need for dialysis
Time frame: up to 30 days
Bleeding
Rate of bleeding complications during admission
Time frame: up to 30 days
Revascularization strategy
Syntax score ( a grading system that evaluates the complexity and prognosis of patients undergoing percutaneous coronary intervention, higher scores denotes more complex disase and higher risk)
Time frame: During procedure
Start is estimated for Oct 2025; primary completion for Aug 2026, 10 months later.
Of 53 interventional studies with no phase under Shock, Cardiogenic, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 55. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Shenzhen Core Medical Technology CO.,LTD. →