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Could early heart pump support save more lives in severe shock?

NCT ID NCT07027202

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether adding a balloon pump early to reduce pressure on the heart improves survival and recovery in 298 adults on ECMO for severe cardiogenic shock. Participants are randomly assigned to early preventive unloading or standard care with rescue unloading only if needed. The goal is to see if early intervention reduces deaths, complications, and time on life support.

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 298 people

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

Started

Mar 2026

Expected to finish

Aug 2027

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. Patient on peripheral femoro-femoral VA ECMO for severe Cardiogenic shock for ≤24h 2. Initiation of LV unloading possible within 12 hours after randomization. 3. Consent obtained from a close relative or surrogate. Should such a person be absent, eligible patients will be randomized according to the specifications of emergency consent and the patient will be asked to give his/her consent for the continuation of the trial when his/her condition will allow. 4. Social security registration (AME excluded) Exclusion Criteria: 1. Age \<18 years 2. Pregnancy 3. Onset of VA-ECMO \>24 h 4. Overt pulmonary edema despite optimization of patient's management (titration of ECMO blood flow, inotropes, non-invasive mechanical ventilation with PEEP, diuretics or hemofiltration) requiring urgent LV unloading 5. ECMO for massive pulmonary embolism or primary RV failure 6. ECMO after heart transplant 7. ECMO after LVAD surgery 8. Resuscitation \>30 minutes before ECMO (cumulative low-flow time), except if the patient has fully recover consciousness at the time of randomization. 9. ECMO for refractory cardiac arrest (E-CPR) 10. Grade 3-4 aortic regurgitation 11. Mechanical complication of acute myocardial infarction (massive mitral regurgitation, pericardium drainage required, septal ventricular defect) 12. Patient moribund on the day of randomization 13. Cerebral deficit with fixed dilated pupils or Irreversible neurological pathology 14. Other severe concomitant disease with limited life expectancy \<1 year 15. Patient has a durable ventricular assist device, an IABP or another temporary mechanical circulatory support (other than ECMO) prior to enrollment. 16. Severe peripheral artery disease or previous aortic or ilio-femoral surgery precluding IABP or IMPELLA insertion.

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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.

Cardiogenic shock acute

How to take part

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

  1. The places running it

    12 sites. 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

  • APHP - hôpital Pitié-Salpêtrière

    RECRUITING

    Paris, 75013, France

  • APHP - hôpital Pitié-Salpêtrière

    NOT_YET_RECRUITING

    Paris, 75013, France

  • APHP - hôpital Pitié-Salpêtrière

    NOT_YET_RECRUITING

    Paris, 75013, France

  • CHRU Nancy - hôpitaux de brabois

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • CHU Clermont-Ferrand - Site Gabriel Montpied

    NOT_YET_RECRUITING

    Clermont-Ferrand, 63000, France

  • Henri Mondor

    NOT_YET_RECRUITING

    Créteil, 94000, France

  • Hôpital Cardiologique

    NOT_YET_RECRUITING

    Lille, 59000, France

  • Hôpital Européen Georges Pompidou

    NOT_YET_RECRUITING

    Paris, 75015, France

  • Hôpital Rangueil

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Hôpital du Pontchaillou

    NOT_YET_RECRUITING

    Rennes, 35033, France

  • Nouvel Hôpital Civil

    NOT_YET_RECRUITING

    Strasbourg, 67000, France

  • Nouvel hôpital civil

    NOT_YET_RECRUITING

    Strasbourg, 67000, France

More trials for these conditions

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