EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

Enrolling by invitation · Not applicable

Conditions studied: Heart Failure, Transplant; Failure, Heart, Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT05610787

Run by

Berlin Heart, Inc

People needed

40

Starts

2022-11-14

Expected to finish

2027-01-01

Last updated by the study team

2026-03-04

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Lucile Packard Children's Hospital-Stanford — Palo Alto, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National — Washington D.C., District of Columbia, United States
• University of Florida - SHands — Gainesville, Florida, United States
• Ann&Robert H Lurie Children's Hospital — Chicago, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• St Louis Children's Hospital — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• Levine Children's Hospital — Charlotte, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Children's Hospital Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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