NCT00266942

Brief Summary

Our aim is a retrospective chart review seeking to determine any differences in the main clinical and outcome variables as well as general outcome data such as functional recovery, readmission rates, somatic growth and mortality. An n size of 150 to 200 for each of the 2 groups will give us excellent power to detect potential differences.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1990

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1990

Completed
16 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

May 23, 2007

Status Verified

May 1, 2007

First QC Date

December 19, 2005

Last Update Submit

May 22, 2007

Conditions

Congenital Disorders

Keywords

Fontan proceduresingle ventricle physiologyintra-atrialextracardiac technique

Eligibility Criteria

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

You may qualify if:

  • Children's Healthcare of Atlanta patients
  • lateral tunnel procedure during 1.1.1990-3.31.2005
  • extracardiac Fontan procedures during 1.1.1990 - 3.31.2005

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

  • Jason M. Budde, MD

    Children's 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 20, 2005

Study Start

January 1, 1990

Study Completion

January 1, 2007

Last Updated

May 23, 2007

Record last verified: 2007-05

Locations

US(1)