NCT00268099

Brief Summary

The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects. The secondary aim being define the criteria for failing medical therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2005

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

May 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

March 16, 2012

Status Verified

June 1, 2007

First QC Date

December 20, 2005

Last Update Submit

March 15, 2012

Conditions

Congenital Disorders

Keywords

pediatriccardiacrepair of right to left shunt lesionsTetralogy of Fallot defects

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect

You may qualify if:

  • patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect

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

  • Brian E Kogon, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Study Start

May 1, 2005

Study Completion

November 1, 2006

Last Updated

March 16, 2012

Record last verified: 2007-06

Locations

US(1)