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

Heart Failure Clinical Trial

Official title:
A Prospective, Multi-center, Single Arm Study to Assess the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (EXCOR® Pediatric)Under a Continued Access Protocol.

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01242891
Study type Expanded Access
Source Berlin Heart, Inc
Contact
Status Approved for marketing
Phase N/A
View Details
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