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NCT00308217 Clinical Trial

Single Ventricle Outcome

Hypoplastic Left Heart Syndrome Clinical Trial

Official title:
The Examination of Outcome in Children With Single Ventricle Physiology

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00308217
Other study ID # 0604-2005
Secondary ID
Status Completed
Phase N/A
First received March 27, 2006
Last updated December 11, 2013
Start date June 2005
Est. completion date June 2005

Study information
Verified date December 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Description:

Congenital disease is the most common cause for infant death from a birth defect. Approximately 30,000 infants are born each year with congenital heart defects.Over one-third of those babies will require cardiac surgery. A particularly lethal cardiac defect is one with single ventricle physiology. The objective of this research proposal is to perform an ongoing single institution prospective clinical trial examining the overall clinical outcome of children with single ventricle physiology.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with single ventricle physiology scheduled for ultimate Fontan surgical palliation at Children's Healthcare of Atlanta will be eligible.

- All subjects must sign informed consent prior to enrollment in study.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

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