Single Ventricle Outcome - Full Text View

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00308217

Purpose

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.

Condition
Heart Disease, Congenital Single Ventricle Hypoplastic Left Heart Syndrome

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	The Examination of Outcome in Children With Single Ventricle Physiology

Further study details as provided by Emory University:

Estimated Enrollment:	30
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2005

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308217

Locations

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Robert M Campbell, MD

Associate Professor, Emory University School of Medicine

More Information

Study ID Numbers:	604-2005
Study First Received:	March 27, 2006
Last Updated:	December 21, 2006
ClinicalTrials.gov Identifier:	NCT00308217
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Heart Disease, Congenital
Single Ventricle
Hypoplastic Left Heart Syndrome

Study placed in the following topic categories:

Heart Diseases
Cardiovascular Abnormalities
Hypoplastic Left Heart Syndrome
Single ventricular heart

Congenital Abnormalities
Hypoplastic left heart syndrome
Heart Defects, Congenital

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009