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Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device

Heart Failure Clinical Trial

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]

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00583661
Study type Interventional
Source Berlin Heart, Inc
Contact
Status Completed
Phase N/A
Start date May 2007
Completion date December 2011
View Details
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