MedTrace Logo

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

NCT00583661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2013-03-15

Study results available
· View outcomes & findings →

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).

Conditions

Interventions

DEVICE

EXCOR Pediatric

Extracorporeal Ventricular Assist Device

Sponsors & Collaborators

  • Berlin Heart, Inc

    lead INDUSTRY

Principal Investigators

  • Charles D Fraser, MD, FACS · Texas Children's Hospital / Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-09-30
Completion
2011-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00583661 on ClinicalTrials.gov