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Enrolling by invitation Not applicable Interventional

EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

ClinicalTrials.gov ID: NCT05610787

Public ClinicalTrials.gov record NCT05610787. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 9:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist Device. EXCOR Active Driving System is intended for use with the approved EXCOR Pediatric VAD. The EXCOR Pediatric VAD is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR Pediatric. EXCOR Active is intended for use in a clinical setting. EXCOR Active can be used in any kind of hospital unit (e.g. OR, ICU, intermediate care unit or general care unit). The driving unit may be moved between clinical units using the caddy or baby buggy; however, a patient must always be accompanied by a person trained in the use of the manual pump and emergency procedures during transport in the event of an emergency. The driving unit can be transported during operation.

Study identification

NCT ID
NCT05610787
Recruitment status
Enrolling by invitation
Study type
Interventional
Phase
Not applicable
Lead sponsor
Berlin Heart, Inc
Industry
Enrollment
40 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 13, 2022
Primary completion
Nov 9, 2023
Completion
Dec 31, 2026
Last update posted
Aug 27, 2026

2022 – 2027

United States locations

U.S. sites
17
U.S. states
15
U.S. cities
17
Facility City State ZIP Site status
Children's Hospital of Los Angeles Los Angeles California 90027
Lucile Packard Children's Hospital-Stanford Palo Alto California 94304
Children's Hospital Colorado Aurora Colorado 80045
Children's National Washington D.C. District of Columbia 20010
University of Florida - SHands Gainesville Florida 32610
Ann&Robert H Lurie Children's Hospital Chicago Illinois 60611
Boston Children's Hospital Boston Massachusetts 02115
CS Mott Children's Hospital Ann Arbor Michigan 48109
St Louis Children's Hospital St Louis Missouri 63110
Columbia University Medical Center New York New York 10032
Levine Children's Hospital Charlotte North Carolina 28203
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Dell Children's Medical Center Austin Texas 78723
Texas Children's Hospital Houston Texas 77030
Primary Children's Hospital Salt Lake City Utah 84113
Children's Hospital Wisconsin Milwaukee Wisconsin 53201

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05610787, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2026 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05610787 live on ClinicalTrials.gov.

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