NCT00266968

Brief Summary

Congenital heart disease affects 1 in 100 newborn babies each year and more than 2,000,000 Americans have a congenital heart defect. One common defect treated at Children's Healthcare of Atlanta at Egleston is single ventricle heart. Due to these overwhelming numbers, the use of diagnostic imaging technology to assess these defects and heart function is an important step in the evolving care of this patient group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2000

Completed
6 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
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

13.9 years

First QC Date

December 19, 2005

Last Update Submit

November 26, 2014

Conditions

Congenital Disorders

Keywords

pediatriccardiacsingle ventricle

Outcome Measures

Primary Outcomes (1)

  • We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies.

    We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies.

    13 years

Eligibility Criteria

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

subjects seen at Children's Healthcare of Atlanta with single ventrical heart

You may qualify if:

  • Single Ventrical heart

You may not qualify if:

  • those patients who do not have single ventrical heart

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 AbnormalitiesUniventricular Heart

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities

Study Officials

  • Angel Cuadrado, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2005

First Posted

December 20, 2005

Study Start

January 1, 2000

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

US(1)