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Single Ventricle Outcome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00308217
First Posted: March 29, 2006
Last Update Posted: December 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert Campbell, MD, Emory University
  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: Time Perspective: Prospective
Official Title: The Examination of Outcome in Children With Single Ventricle Physiology

Resource links provided by NLM:


Further study details as provided by Robert Campbell, MD, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Robert Campbell, MD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00308217     History of Changes
Other Study ID Numbers: 0604-2005
First Submitted: March 27, 2006
First Posted: March 29, 2006
Last Update Posted: December 12, 2013
Last Verified: December 2013

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

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