An interventional study of EVAS Treatment in Cardiogenic Shock, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
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 13th largest by planned enrollment of the 14 interventional ones, is one of 4 that started in 2026, is one of 12 with no phase, reaches primary completion later than 16 of the 17 other live ones, and was the 20th registered.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →18 of the 20 studies in Shock, Cardiogenic with a site in China are open now, in 1 country. Each count lists the studies.
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 and older · all sexes · no healthy volunteers.
The full table on the hub →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 2026.
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.
3 of 20 have an industry lead sponsor. The 10 most frequent:
China National Center for Cardiovascular Diseases is the lead sponsor of 269 studies on the registry; 141 are open to participants now.
China National Center for Cardiovascular Diseases has 1 study 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 |
Among the 20 studies in Shock, Cardiogenic with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
Study Title: Safety and Efficacy of Extracorporeal Ventricular Assist System for Cardiogenic Shock: A Prospective, Multicenter, Single-Arm Clinical Study Objective: To evaluate the safety and efficacy of temporary mechanical circulatory support and bridge therapy with an extracorporeal ventricular assist system in patients with cardiogenic shock or weaning failure from cardiopulmonary bypass, and to comprehensively assess the device, pump head, cannulae and tubing.
Pilot Phase: Clinical validation of Class III medical device. Study Design: Prospective, multicenter, single-arm target-value design. Sample Size: 40 patients. Primary Endpoint: Success rate of mechanical circulatory support.
Secondary Endpoints:
30-day survival after transition to long-term therapy (VAD/transplant); 30-day cardiovascular mortality after device explantation; MACCE incidence; Mean support duration; Incidence of bleeding, thrombosis, hematologic events, acute renal/hepatic dysfunction, infection; Hemodynamic trends during support; Changes in SCr, BUN, ALT, TBIL at use, discharge and 30 days post-explantation vs baseline; Device satisfaction. Follow-up: Within 6 hours of initiation, during support, 24 hours, 7 days, 30 days post-explantation/transition, and at discharge.
All clinical data were collected, managed and analyzed by an independent data and statistical center and clinical monitoring unit to support safety/efficacy evaluation and market approval.
Inclusion Criteria:(1) The subject voluntarily participates in the study and has signed the form; (2) Age ≥ 18 years; (3) Subjects diagnosed with cardiogenic shock or low cardiac output syndrome meeting one of the following clinical scenarios: Unstable circulation secondary to low cardiac output after cardiac surgery, or inability to wean from cardiopulmonary bypass during surgery; Acute decompensation of heart failure (including ischemic cardiomyopathy, dilated cardiomyopathy, etc.) with persistent hemodynamic instability despite conventional pharmacotherapy and IABP support; Hemodynamic instability in patients with end-stage heart failure prior to heart transplantation or transition to other long-term therapeutic strategies.
(4) Cardiogenic shock shall meet the following criteria:
Signs of inadequate perfusion (at least one item):
① Altered mental status unexplainable by other causes: agitation in the early stage, lethargy and stupor in the late stage;
Hypotension with adequate intravascular volume (at least one item):
Laboratory or hemodynamic findings (at least one item):
Hemodynamics: Cardiac Index (CI) ≤2.2 L/min·m², Pulmonary Capillary Wedge Pressure (PCWP) ≥15 mmHg;
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: EVAS Treatment
Using interventional implantation of blood conduits into the left cardiac system, an extracorporeal pump shunts blood to the arterial system to partially or fully substitute cardiac pumping function and sustain systemic circulation.
Success rate of extracorporeal mechanical circulatory support using the investigational extracorporeal ventricular assist system
30-day survival following explantation of the extracorporeal ventricular assist system
Time frame: 30-day
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2028, 33 months after the start.
Of 49 non-industry 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 33 months is below that.
Counting every sponsor, half of 53 studies reached it within 39 months; a quarter within 24 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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China National Center for Cardiovascular Diseases →