We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol (CAP)

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242891
First Posted: November 17, 2010
Last Update Posted: March 6, 2012
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.
Information provided by (Responsible Party):
Berlin Heart, Inc
November 16, 2010
November 17, 2010
March 6, 2012
 
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.
The data collection and protocols for this study remain consistent with the main IDE study for the EXCOR® Pediatric Ventricular Assist Device. This protocol was closed at the same time as the main IDE study due to FDA approval (December 16, 2011).
Expanded Access
Device: EXCOR® Pediatric Ventricular Assist Device
Extracorporeal Ventricular Assist Device
Other Names:
  • Berlin Heart
  • EXCOR®
  • EXCOR® Pediatric
  • EXCOR® Pediatric VAD
Not Provided
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01242891
Berlin Heart, Inc
Berlin Heart, Inc
Not Provided
Principal Investigator: All Previous IDE Sites See IDE Clinical Trials Listing for IDE Study
Berlin Heart, Inc
March 2012