Offered by: Nemours
Location: Delaware Valley
What is the trial about?
In December 2011, the FDA approved the use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device ("EXCOR® Device"). The EXCOR® Device is approved as a Humanitarian Use Device (HUD). The FDA has requested that Berlin Heart (the company which makes the device) continue to study the device in order to gather more data to show to the FDA.
Who can participate?
This study will include patients who are receiving support using the Berlin Heart EXCOR® Device.
What is involved?
Patients will be followed while they are implanted with the EXCOR® Device and for 24 months after the device is removed.
Data will be collected from tests, exams and procedures that are related to the EXCOR® Device.
Contact Nemours Clinical Trials
Trial Name: EXCOR® Pediatric Ventricular Assist Device Post Approval Study