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Single Ventricle Outcome

This study has been completed.
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00308217
First received: March 27, 2006
Last updated: December 21, 2006
Last verified: December 2006
History of Changes
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

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

No publications provided

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

Keywords provided by Emory University:
Heart Disease, Congenital
Single Ventricle
Hypoplastic Left Heart Syndrome

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Hypoplastic Left Heart Syndrome
 Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on June 18, 2013