NCT00583661

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

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]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Berlin Heart, Inc · Industry
• Sex: All
• Age: 1 Day – 16 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Heart Failure
• Cardiomyopathies

Interventions

Type	Name	Description
DEVICE	EXCOR Pediatric	Extracorporeal Ventricular Assist Device

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-09-01
• Completion: 2011-12-01
• First posted: 2007-12-31
• Last updated: 2013-03-15
• Results posted: 2013-03-15

Locations

17 sites across 2 countries: United States, Canada