- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00308217
Single Ventricle Outcome
December 11, 2013 updated by: Robert Campbell, MD, Emory University
The Examination of Outcome in Children 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 Overview
Status
Completed
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 Type
Observational
Enrollment
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert M Campbell, MD, Associate Professor, Emory University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
March 27, 2006
First Submitted That Met QC Criteria
March 27, 2006
First Posted (Estimate)
March 29, 2006
Study Record Updates
Last Update Posted (Estimate)
December 12, 2013
Last Update Submitted That Met QC Criteria
December 11, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0604-2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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