Congenital Heart Disease Clinical Trial
Official title:
A Review of the Diagnosis, Treatment and Outcomes of Children With Critical Congenital Heart Defects
NCT number | NCT00208689 |
Other study ID # | 1058-2003 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | September 13, 2005 |
Last updated | February 11, 2014 |
Start date | January 2004 |
Verified date | February 2014 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 150 |
Est. completion date | |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
Inclusion Criteria: - Critical congenital heart disease - Signed informed consent Exclusion Criteria: - Not diagnosed with critical congenital heart disease - No signed informed consent |
N/A
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
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