Can a temporary heart pump save more lives in cardiogenic shock?

NCT ID NCT07762560

Disease control Sponsor: Leipzig Heart Science gGmbH Source: ClinicalTrials.gov ↗

First seen Aug 13, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This trial investigates whether using a temporary heart pump (microaxial flow pump) right after opening a blocked artery improves survival in people with cardiogenic shock—a life-threatening condition where the heart can't pump enough blood. It also tests whether advanced monitoring with a pulmonary artery catheter, which guides precise medication adjustments, helps more than standard ICU monitoring. Adults with heart attack-related shock are randomly assigned to one of four combinations of these treatments. The main goal is to see if these strategies reduce the risk of death within 180 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Microaxial flow pump (a temporary heart pump) and pulmonary artery catheter (a monitoring device)
What this could lead to: If effective, this could establish a new standard of care for cardiogenic shock after a heart attack, potentially improving survival rates.
What could go wrong: The trial is large but early-stage, and the devices carry risks like bleeding, infection, or vascular damage. Results may not apply to all patients.

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

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

About 780 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2037

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these: 1. Planned immediate angiography and revascularization (preferred PCI) 2. Systolic blood pressure \<100 mmHg or catecholamines required to maintain pressure \>90 mmHg during systole 3. Arterial lactate \>2.0 mmol/L 4. Echocardiogram with LVEF \<40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm Exclusion Criteria: 1. Age \<18 and \>80 years 2. Shock duration \>12 hours 3. Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis). 4. Shock due to mechanical complication of AMI 5. Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression \>10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression \<10 min are also eligible) 6. After 390 included patients with OHCA, any OHCA will be an exclusion criterion 7. Any unwitnessed OHCA 8. Refractory cardiac arrest with ongoing chest compression 9. Evidence of severe right ventricular failure 10. Severe aorta valve regurgitation/stenosis 11. Severe peripheral arterial obstructive disease precluding mAFP placement 12. Abnormalities of the aorta precluding mAFP device placement 13. Presence of a mechanical aortic valve prosthesis 14. Left ventricular thrombus 15. Infective endocarditis 16. Life expectancy \<1 year due to comorbidities 17. Mental disorder or language barrier that preclude informed consent 18. Known pregnancy

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction cardiogenic shock heart failure Shock, Cardiogenic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myocardial infarction (AMI) Cardiogenic shock Heart failure, acute

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
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.

Can a temporary heart pump save more lives in cardiogenic shock?

What the study statuses mean