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Balloon in the aorta could boost CPR success in cardiac arrest

NCT ID NCT04596514

Disease control Sponsor: St. Olavs Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial tests whether placing a balloon in the aorta (REBOA) during CPR can improve blood flow to the heart and brain in people who have a cardiac arrest outside the hospital. The study includes 200 adults with non-traumatic cardiac arrest who receive CPR within 10 minutes. Researchers compare standard CPR to CPR plus REBOA to see if the balloon helps restore a stable heartbeat and improves survival with good brain function.

What this could mean

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

Active substance
a balloon device called REBOA (resuscitative endovascular balloon occlusion of the aorta) placed inside the aorta during CPR
What this could lead to
If it works, this could provide a new way to improve blood flow to the heart and brain during CPR, potentially increasing survival after cardiac arrest.
What could go wrong
This is the first prospective trial of its kind, so results are uncertain. The procedure is invasive and may not improve outcomes or could cause complications.

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

200 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Jul 2026

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: * out-of-hospital cardiac arrest * non-traumatic cardiac arrest * less than 10 minutes from debut of arrest to start of basic or advanced cardiac life support * advanced cardiac life support is established and can be continued Exclusion Criteria: * traumatic cardiac arrest, including strangulation, electrocution and patients rescued from avalanches * accidental hypothermia with temperature \< 32 0C * suspected cerebral hemorrhage as etiology of the arrest * suspected non-traumatic hemorrhage as etiology of the arrest * pregnancy, obvious or suspected * patient included to the study site's E-CPR protocol * other factors as decided by the treatment team (environmental factors, safety factors and others)

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Conditions

The condition(s) this trial relates to.

cardiac arrest

As listed by the trial registrant

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

Cardiac arrest

Contacts and locations

Locations

  • Aarhus Base

    Aarhus, Denmark

  • Billund HEMS-base

    Billund, Denmark

  • Drammen Hospital

    Drammen, Norway

  • Haukeland University Hospital

    Bergen, Norway

  • Lørenskog HEMS Unit

    Oslo, Norway

  • Maggiore Hospital

    Bologna, Italy

  • Rapid response car - 119 Oslo

    Oslo, Norway

  • Ringsted HEMS-base

    Ringsted, Denmark

  • Skive HEMS

    Skive, Denmark

  • St Olavs Hospital

    Trondheim, 7030, Norway

  • Stavanger University Hospital

    Stavanger, 4068, Norway

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