Single Ventricle Outcome

Completed

• Conditions: Hypoplastic Left Heart Syndrome; Heart Disease, Congenital; Single Ventricle

• Registration Number: NCT00308217
• Lead Sponsor: Emory University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-29
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States