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New heart pump driver could be lifeline for kids awaiting transplants

NCT ID NCT05610787

Disease control Sponsor: Berlin Heart, Inc 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study is testing a new driving system for the EXCOR Pediatric heart pump, which helps children with severe heart failure while they wait for a heart transplant. About 40 children will take part to see if the new driver works safely and effectively. The goal is to keep patients alive and stable until a donor heart becomes available.

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 40 people

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

Started

Nov 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 21 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: * Patient meets all indications as specified in the current version of the Instructions for Use (IFU) of the EXCOR® Pediatric VAD system as shown below: "EXCOR is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric patients with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using EXCOR." • Patient and/or legal representative has signed the study informed consent form. Exclusion Criteria: • Patient has any contraindication as specified in the current version of the IFU of the EXCOR® Pediatric VAD system as shown below: "Patients unable to tolerate systemic anticoagulation therapy should not be implanted with EXCOR components. Magnetic Resonance Imaging (MRI) is contraindicated in patients after being implanted with EXCOR. Patients with aortic valve regurgitation that is more than moderate that cannot be re- paired at the time of implantation should not be implanted with EXCOR. If repair of the aortic valve regurgitation requires surgical closure of the aortic valve, EXCOR should not be implanted. EXCOR is not intended to be used as a total artificial heart and should not be used in this configuration." * Patient and/or legal representative has not given written consent to participate in the study (non-consent). * Females of childbearing age who are not on contraceptives or surgically sterile or pregnant.

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Conditions

The condition(s) this trial relates to.

congenital heart disease heart failure

As listed by the trial registrant

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

Congenital heart disease Heart failure Transplant, failure, heart

How to take part

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

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Ann&Robert H Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • CS Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Wisconsin

    Milwaukee, Wisconsin, 53201, United States

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's National

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dell Children's Medical Center

    Austin, Texas, 78723, United States

  • Levine Children's Hospital

    Charlotte, North Carolina, 28203, United States

  • Lucile Packard Children's Hospital-Stanford

    Palo Alto, California, 94304, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • St Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of Florida - SHands

    Gainesville, Florida, 32610, United States

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