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Can a simple heart pump save lives after a heart attack complication?

NCT ID NCT07267884

Disease control Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether inserting a heart pump (IABP) early, before severe shock develops, can reduce deaths in patients who develop a hole in the heart after a heart attack. The trial will enroll 100 patients across 5 centers, randomly assigning half to receive the pump within 8 hours plus standard care, and half to standard care alone. The main goal is to see if early pump use lowers the chance of dying within 30 days.

What this could mean

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

Active substance
Intra-aortic balloon pump (IABP) - a device inserted into the main artery to help the heart pump blood
What this could lead to
If successful, this could show that early IABP use reduces deaths in patients with a hole in the heart after a heart attack, offering a bridge to surgery.
What could go wrong
This is a small, early-stage trial (100 patients) and previous larger studies found IABP did not improve survival in similar conditions. The device also carries risks like bleeding or infection.

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 100 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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 75 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: * Age between 18 and 75 years; * Diagnosed with AMI based on clinical manifestations, electrocardiogram, cardiac troponin markers, etc.; * Diagnosis of MI-VSD by echocardiography; * Patients in stage B according to the SCAI shock stage definition before enrollment, meeting the following conditions: (1) good mental status, (2) warm limbs without cold and clammy feeling, (3) Killip class 2, with the beginning of wet rales at the lung bases, (4) arterial blood lactate ≤ 2mmol/L, (5) normal renal function or mild renal impairment (creatinine increase less than 1.5 times baseline or eGFR decrease ≤ 50%), (6) no use of vasoactive drugs; * Obtain informed consent. Exclusion Criteria: * Age \> 75 years; * Congenital heart disease with ventricular septal defect; * Complications such as free wall rupture, papillary muscle dysfunction, etc.; * Typical cardiogenic shock (SCAI shock stages C-E) before enrollment, any of the following: (1) altered mental status, (2) cold and clammy skin, (3) Killip class 3 or 4, (4) arterial blood lactate \> 2mmol/L, (5) severe liver and kidney function impairment, (6) use of vasoactive drugs to maintain blood pressure; or in shock risk period (stage A); * Chronic end-stage organ dysfunction that is not expected to be suitable for surgical treatment; * Shock caused by other reasons (such as sepsis or hypovolemia); * Patients with an expected life span of less than 12 months; * Aortic valve insufficiency more than grade II, aortic dissection or aneurysm cannot be ruled out; * Difficulty in implanting IABP due to severe peripheral vascular disease or other reasons; * Pregnancy and lactation; * Refusal to sign the informed consent form, disagreement to insert IABP, or no willingness to proceed with further surgical treatment.

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction Shock, Cardiogenic ventricular septal defect

As listed by the trial registrant

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

Acute myocardial infarction (AMI) Ventricular septal defects (VSD)

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Department of Cardiology, Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.