NCT00486070

Brief Summary

This is a retrospective review of charts and echocardiograms of our patients with Total Anomalous Pulmonary Venous Connection (TAPVC). The Children's Surgical and non-invasive Echo databases will be used to determine all TAPVC patients. Children's Healthcare of Atlanta and Sibley Heart Center Cardiology charts and echocardiograms of the TAPVC patients between January 1, 2002 and November 26, 2006 will be reviewed. We anticipate approximately 40 patients. We hypothesize that the presence of descending aortic flow reversal correlates with a higher morbidity and mortality in TAPVC.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2006

Shorter than 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

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 16, 2012

Status Verified

January 1, 2008

First QC Date

June 12, 2007

Last Update Submit

March 14, 2012

Conditions

Keywords

cardiac anomalypulmonary veinscyanosisflow reversalTAPAVC

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

TAPVC patients

You may qualify if:

  • Children's Healthcare of Atlanta and Sibley Heart Center Cardiology charts and echocardiograms of the TAPVC patients between January 1, 2002 and November 26, 2006 will be reviewed. We anticipate approximately 40 patients.
  • The patients with TAPVC will be divided into two groups by the presence or absence of descending aortic flow reversal.

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 AbnormalitiesHeart Defects, CongenitalCyanosis

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Derek A Fyfe, MD, PhD

    Sibley Heart Center Cardiology at Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 13, 2007

Study Start

December 1, 2006

Study Completion

September 1, 2007

Last Updated

March 16, 2012

Record last verified: 2008-01

Locations