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NCT05610787

EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

Enrolling by Invitation
NAUp to 21InterventionalTreatment
Berlin Heart, Inc
~40 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:EXCOR Active Driving System for Pediatric VAD

At a glance

Recruiting sites
0 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Device Malfunction adverse events
Measured over Up to 90 days
+2 more outcomes measured

Conditions

Heart Failure
Transplant; Failure, Heart
Congenital Heart Disease

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NCT05610787

Where you'd take part

This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ann&Robert H Lurie Children's Hospital

    Chicago, Illinoisno site contact published

  • Boston Children's Hospital

    Boston, Massachusettsno site contact published

  • Children's Hospital Colorado

    Aurora, Coloradono site contact published

  • Children's Hospital of Los Angeles

    Los Angeles, Californiano site contact published

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniano site contact published

  • Children's Hospital Wisconsin

    Milwaukee, Wisconsinno site contact published

  • Children's National

    Washington D.C., District of Columbiano site contact published

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

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Eligibility criteria

Inclusion

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:

Exclusion

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.

What this trial measures

  • Rate of Device Malfunction adverse eventsUp to 90 days

    A Device Malfunction per protocol definition, and adjudicated by the Clinical Events Committee.

  • Patient OutcomeUp to 90 days

    Patient outcomes will be summarized as the proportion of subjects experiencing each outcome and the overall successful outcome. Successful outcome is defined as: * survival to recovery/successful weaning -or- * survival to explantation not attributed to device malfunction -or- * survival on EXCOR® Pediatric at 90 days post-implant Patients who are removed from support followed by death or for escalation to other therapy (such as another VAD or ECMO) due to major device malfunction attributed to the Active Driving System will be considered failures.

  • Serious Adverse EventsUp to 90 days

    Serious Adverse Event rates will be calculated as the rate per 100 patient-months for each individual event as defined in protocol.