Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00583661|
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : March 15, 2013
Last Update Posted : March 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Cardiomyopathies||Device: EXCOR Pediatric||Not Applicable|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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]|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||December 2011|
Experimental: EXCOR Pediatric
Implantation of the EXCOR Pediatric Ventricular Assist Device
Device: EXCOR Pediatric
Extracorporeal Ventricular Assist Device
- 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 ]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 ]Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583661
|Principal Investigator:||Charles D Fraser, MD, FACS||Texas Children's Hospital / Baylor College of Medicine|