NCT00208689

Brief Summary

Congenital heart disease in infants and children often challenges healthcare providers both in regards to diagnosis and in the management of these conditions. The field becomes more complicated as one examines the myriad of defects that present and the complex care that is required. Over the last 20-25 years, the remarkable advances in the medical and surgical management of the most complex lesions have decreased neonatal mortality, such that many more survive the neonatal period. Therefore, new challenges regarding the continued care of this patient cohort of high-risk infants and children exist. In order to continue the improvement of treatment(s) offered to these patients, continuous review and analysis of the current standard of care is needed. In this study, the investigators will collect information related to the current surgical and medical therapies offered to patients enrolled in the High Risk Congenital Heart Program at Children's Healthcare of Atlanta. All of the procedure and visit information will be a part of the child's standard of care. This information will be placed in a database. The investigators hope to learn more about the short-term and long-term effects of current therapies and procedures.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-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, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

February 11, 2014

Conditions

Congenital Heart Disease

Keywords

pediatriccongenital heart disease

Eligibility Criteria

Age1 Day - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Critical congenital heart disease
  • Signed informed consent

You may not qualify if:

  • Not diagnosed with critical congenital heart disease
  • No signed informed consent

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

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Martha Clabby, MD

    Emory University and Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2004

Primary Completion

May 1, 2006

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

US(1)