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Balloon pump may boost heart recovery in shock patients on ECMO

NCT ID NCT06336655

Disease control Sponsor: University of Utah Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a balloon pump (IABP) to standard ECMO support helps the heart recover better in people with severe cardiogenic shock. About 104 adults will be randomly assigned to get ECMO alone or ECMO plus the balloon pump. Researchers will measure heart function and fluid buildup over five days to see if the extra device makes a difference.

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)
What this could lead to
If it works, this could show that adding a balloon pump to VA ECMO helps the heart recover better in people with severe cardiogenic shock.
What could go wrong
This is a Phase 2 trial with only 104 participants, so results are preliminary. The intervention may not improve outcomes and 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 104 people

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

Started

Oct 2024

Expected to finish

Feb 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 years and older

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: * Adult patients (age 18 years or older) * Diagnosis of acute cardiogenic shock (CS) * Patients failing medical therapy, defined as 1 or more of the following: 1. Society for Coronary Angiography and Interventions (SCAI) Stage C or greater 2. 2 or more inotropic medications and not improving 3. IABP in place and clinically worsening 4. Placed on VA ECMO for CS 5. In the opinion of the attending physician, patient has worsening CS and could require VA ECMO support in the near-term Exclusion Criteria: * Metastatic or stage 4 cancer * Atrial septostomy * Planned LV unloading on ECMO * Anticipated death \<72 hours * Existing durable left ventricular assist device (dLVAD) * Unwillingness to randomize * Patients who are pregnant

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Conditions

The condition(s) this trial relates to.

cardiogenic shock Shock, Cardiogenic

As listed by the trial registrant

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

Cardiogenic shock

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

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

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