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New Heart-Lung device could save kids with severe heart failure

NCT ID NCT06080074

Disease control Sponsor: Stanford University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 11, 2026 · Updated 4 times

Summary

This study tests a compact heart-lung machine called Cardiohelp in 50 children with severe heart failure. The device supports the heart for up to 30 days while kids recover or await a transplant. The trial also compares two blood thinners to see which causes fewer bleeding or clotting problems. The goal is to get the device FDA-approved for children.

What this could mean

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

Active substance
Cardiohelp device (VA-ECMO) and blood thinners (heparin or bivalirudin)
What this could lead to
If successful, this could lead to FDA approval of the Cardiohelp device for longer-term use in children with severe heart failure, and identify a safer blood thinner for these patients.
What could go wrong
This is a Phase 2 trial with only 50 children, so results are preliminary. The device is used off-label, and risks like stroke, bleeding, and organ failure are possible.

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 50 people

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

Started

Apr 2025

Expected to finish

Sep 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

0 to 16 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: 1. Age 0 to 16 years of age (i.e., \<17 years) 2. Body weight 2.5 to 80 kilograms 3. VA-ECMO use for primary cardiac failure using the Cardiohelp system. 4. First ECMO run during the current hospitalization 5. Written informed consent from the parent or legally appointed representative (LAR) Exclusion Criteria:Children must not meet any of the following exclusion criteria after ECMO cannulation and immediately prior to consent: 1. Gestationally-corrected age \<37 weeks 2. Bleeding or coagulopathy that is a contraindication to anticoagulation 3. Irreversible renal, hepatic or lung failure 4. Stroke or uncertain neurological status within the past 30 days 5. Severely malnourished 6. Use of an ECMO system other than the Cardiohelp 7. VV-ECMO or ECMO for primary respiratory failure 8. Goals of patient to focus on comfort measures only. 9. Failure to separate from cardiopulmonary bypass 10. Allergy or contraindication to receiving UFH or bivalirudin as a primary anticoagulant on ECMO. 11. Patients who are pregnant or breastfeeding. 12. Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)

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Conditions

The condition(s) this trial relates to.

cardiogenic shock cardiomyopathy congenital heart disease heart failure Shock, Cardiogenic

As listed by the trial registrant

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

Cardiogenic shock Cardiomyopathies Congenital heart disease Heart failure

How to take part

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

  1. The places running it

    5 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

  • Children's Health Dallas

    RECRUITING

    Dallas, Texas, 95235, United States

  • Cuimc/Nyph

    RECRUITING

    New York, New York, 10032, United States

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Lucile Packard Children's Hospital

    RECRUITING

    Palo Alto, California, 94304, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

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