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Balloon pump after ECMO: could it save more hearts?

NCT ID NCT06872021

Disease control Sponsor: Beijing Anzhen Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether placing a special balloon pump (IABP) early after starting ECMO can improve survival in adults with cardiogenic shock—a life-threatening condition where the heart can't pump enough blood. About 358 participants will be randomly assigned to get the balloon pump or standard care. The main goal is to see if the balloon pump reduces deaths within 30 days.

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 358 people

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

Started

Mar 2026

Expected to finish

Dec 2028

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: 1. Age of ≥18 2. Cardiogenic shock(defined as a systolic blood pressure of less than 90 mm Hg for more than 30 minutes or the initiation of catecholamines to maintain a systolic pressure of more than 90 mm Hg, an arterial lactate level of more than 3 mmol per liter, and signs of impaired organ perfusion) 3. Successful implantation of VA-ECMO 4. Informed consent Exclusion Criteria: 1. SCAI shock stage A or B 2. Presence of moderate to severe aortic insufficiency or aortic dissection 3. Severe peripheral vascular disease 4. Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD). 5. VA-ECMO for definite non-cardiac causes 6. Isolated right ventricular failure 7. V-A ECMO usage confined to the period during surgery or other interventions 8. Ischemic mechanical complications(eg Ventricular septal defect, papillary muscle rupture) 9. Extracorporeal cardiopulmonary resuscitation 10. LVAD, Impella or IABP in situ. 11. Severe bleeding 12. Terminal malignancy 13. Irreversible neurologic injury 14. Pregnancy or lactation

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Conditions

The condition(s) this trial relates to.

cardiogenic shock

As listed by the trial registrant

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

ECMO

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

  • Beijing Anzhen Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

More trials for these conditions

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