Can an external heart pump keep shock patients alive?
NCT ID NCT07769528
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial tests an external ventricular assist device that temporarily takes over the heart's pumping function in people with cardiogenic shock—a condition where the heart can't pump enough blood. The study enrolls 40 adults who have shock after heart surgery, can't come off a heart-lung machine, or have acute heart failure. The main goal is to see if the device can successfully support circulation and improve 30-day survival after it's removed, while also tracking safety issues like bleeding, clotting, and organ function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Extracorporeal ventricular assist system (EVAS) - an external pump that temporarily takes over heart function to maintain blood flow
- What this could lead to
- If successful, this device could offer a life-saving bridge for people in cardiogenic shock, helping them survive until their heart recovers or they receive a transplant or long-term assist device.
- What could go wrong
- This is an early pilot study with only 40 patients, so results may not apply broadly. The device carries risks like bleeding, clotting, infection, and organ dysfunction, and it may not improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria:(1) The subject voluntarily participates in the study and has signed the informed consent 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; * Cool, clammy and mottled skin of extremities; ③ Oliguria (\<30 mL/h or 0.5 mL/kg/h). Hypotension with adequate intravascular volume (at least one item): * Systolic blood pressure ≤90 mmHg or mean arterial pressure ≤60 mmHg lasting more than 30 minutes; ② Requirement for vasoactive agents or inotropic agents to maintain systolic blood pressure ≥90 mmHg; ③ Systolic blood pressure ≥90 mmHg after excluding trauma, intoxication, hypoxia and other factors, accompanied by obvious manifestations of hypoperfusion. Laboratory or hemodynamic findings (at least one item): * Hemodynamics: Cardiac Index (CI) ≤2.2 L/min·m², Pulmonary Capillary Wedge Pressure (PCWP) ≥15 mmHg; * Laboratory test: Lactate ≥2 mmol/L; ③ Serum creatinine increased to 1.5 times the baseline value, or glomerular filtration rate decreased by \>50%; ④ ALT elevated to 3 times the upper limit of normal. (5) Authorized clinicians confirm that all feasible measures have been implemented to correct abnormalities of arterial blood gas, electrolyte disorders, hypovolemia, hypervolemia, bradycardia, arrhythmia and incomplete rewarming. Exclusion Criteria: * (1) Patients who fail to comply with medical treatment protocols; (2) Patients with established irreversible central nervous system injury; (3) Patients intolerant to anticoagulants (such as heparin or equivalent alternatives); (4) Patients with severe infection, malignant tumor, or end-stage multiple organ failure; (5) Patients with implanted mechanical heart valves, moderate to severe aortic regurgitation, or unrepaired structural cardiac lesions (e.g., ventricular septal rupture); (6) Patients with severe peripheral vascular disease or irreversible neurological/neuromuscular disorders; (7) Patients with pulmonary embolism, pulmonary infarction, or uncorrectable pulmonary hypertension; (8) Patients with psychiatric disorders requiring long-term standardized treatment or relevant medical history, drug abusers, and patients positive for HIV or syphilis; (9) Patients with a history of stroke or transient ischemic attack (TIA) within the past 3 months; (10) Patients with active bleeding or disorders of coagulation; (11) Female patients during pregnancy; (12) Patients who have participated in another clinical trial within 1 month, or are currently participating in another clinical trial that has not reached its endpoint; (13) Patients with other conditions deemed ineligible for this trial by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fuwai Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 100000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stick-On patch aims to catch dangerous heart decline sooner
- Heart pump timing put to the test in deadly heart attack shock
- A second chance for the heart: can rehab rewrite the story after shock?
- Blood filter may calm the deadly inflammation of cardiogenic shock
- Microscopic blood vessel health may hold key to cardiogenic shock survival
- Can a machine support a failing heart without overworking it?