NCT00267423

Brief Summary

Hypothesis 1 (H1): Epicardial biventricular pacing is a safe and feasible method of pacing in young patients. Over the last two years, physicians at Children's Healthcare of Atlanta have been implanting epicardial BiV pacing systems in children determined to have ventricular dyssynchrony caused by numerous cardiac diagnoses. The decision to use these pacing systems was based on the knowledge gained by adult studies. Since the use of these pacing systems in the pediatric population has not been formally studied, we propose a study to retrospectively review the safety and feasibility of epicardial BiV pacing in pediatric patients. This study will involve the review of the medical records of children who received epicardial BiV systems at Children's Healthcare of Atlanta between January 2002 and May 2004.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
Last Updated

May 4, 2007

Status Verified

May 1, 2007

First QC Date

December 19, 2005

Last Update Submit

May 2, 2007

Conditions

Congenital Disorders

Keywords

pediatriccardiacelectrophysiologyepicardial biventricular pacing

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • any pediatric patient who received an epicardial BiV pacing system at Children's Healthcare of Atlanta between January 2002 and May 2004.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Patrick A Frias, MD

    Sibley Heart Center Cardiology at Children't Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 21, 2005

Study Start

January 1, 2002

Last Updated

May 4, 2007

Record last verified: 2007-05

Locations

US(1)