Tests a pump-driving device for children with severe heart failure awaiting transplant
Tests a device that drives a heart pump in children with heart failure awaiting transplant.
Plain-language title generated from the registry record
Registry title: EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Key facts
- Where
- Ann Arbor, Aurora, Austin, Boston, Charlotte, Chicago, Cincinnati, Gainesville, Houston, Los Angeles, Milwaukee, New York, Palo Alto, Philadelphia, Salt Lake City, St Louis, and Washington D.C., United StatesSee the 17 sites
Where in United States
- CS Mott Children's HospitalAnn Arbor, United StatesNo longer taking part
- Children's Hospital ColoradoAurora, United StatesNo longer taking part
- Dell Children's Medical CenterAustin, United StatesNo longer taking part
- Boston Children's HospitalBoston, United StatesNo longer taking part
- Levine Children's HospitalCharlotte, United StatesNo longer taking part
- Ann & Robert H. Lurie Children's HospitalChicago, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesNo longer taking part
- University of Florida - ShandsGainesville, United StatesNo longer taking part
- Texas Children's HospitalHouston, United StatesNo longer taking part
- Children's Hospital of Los AngelesLos Angeles, United StatesNo longer taking part
- Children's Hospital WisconsinMilwaukee, United StatesNo longer taking part
- Columbia University Medical CenterNew York, United StatesNo longer taking part
- Lucile Packard Children's Hospital - StanfordPalo Alto, United StatesNo longer taking part
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesNo longer taking part
- Primary Children's HospitalSalt Lake City, United StatesNo longer taking part
- St. Louis Children's HospitalSt Louis, United StatesNo longer taking part
- Children's NationalWashington D.C., United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Berlin Heart, Inc
- Trial code
- NCT05610787
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
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.
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:; "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: 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."; Females of childbearing age who are not on contraceptives or surgically sterile or pregnant; Patient and/or legal representative has not given written consent to participate in the study (non-consent).