Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and Drug Administration under a Humanitarian Device Exception (HDE).
An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Multi-center, Single Arm Study to Access the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device [EXCOR Pediatric]|
- The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device. [ Time Frame: Participants were followed while on device support, an average of 58 days ] [ Designated as safety issue: Yes ]The serious adverse event rate was calculated by totaling the number of serious adverse events all subjects experienced during device support (from implant to explant, an average of 58 days) divided by the total support time (in days) for all subjects. The serious adverse event rates were calculated separately for each primary study cohort.
- Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device. [ Time Frame: Participants were followed while on device support, an average of 58 days ] [ Designated as safety issue: No ]Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.
|Study Start Date:||May 2007|
|Study Completion Date:||December 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Experimental: EXCOR Pediatric
Implantation of the EXCOR Pediatric Ventricular Assist Device
Device: EXCOR Pediatric
Extracorporeal Ventricular Assist Device
Berlin Heart Inc. is sponsoring a prospective, multi-center, single arm study to access the safety and probable benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device [EXCOR® Pediatric]. The study will compare the EXCOR® Pediatric with a historical control population supported with extra-corporeal membrane oxygenation (ECMO) as a bridge to cardiac transplantation in children.
Show 17 Study Locations
|Principal Investigator:||Charles D Fraser, MD, FACS||Texas Children's Hospital / Baylor College of Medicine|