EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study (NCT05610787) | Clinical Trial Compass
By InvitationNot Applicable
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
United States40 participantsStarted 2022-11-14
Plain-language summary
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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.