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Outcomes Following Pulmonary Valve Replacement in Adults

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. Identifier: NCT00276237
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : November 26, 2013
Information provided by (Responsible Party):
Brian Kogon, Emory University

Brief Summary:

One of the most common residual lesions in adult survivors of pediatric cardiac surgery is pulmonary valve disease, particularly regurgitation.

Multiple studies have demonstrated that placement of a pulmonary valve in such patients, results in improved ventricular function and resolution of symptoms. However, the optimal prosthetic valve for use in the pulmonary position has not been defined. There are essentially three alternatives available: the stented bioprosthetic valve, stentless bioprosthetic "tube" grafts used to replace the entire right ventricular outflow tract and mechanical valves.

All three of these valve options have been used in adults with congenital heart disease at Emory Healthcare and at Children's Healthcare of Atlanta at Egleston.

The goal of this study is to evaluate and compare the indications and short and mid-term outcomes for these alternative therapies.

Condition or disease
Heart Disease, Congenital Pulmonary Valve Replacement

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Study Type : Observational
Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Review of Outcomes Following Pulmonary Valve Replacement for Congenital Heart Disease in Adults
Study Start Date : July 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Adult patients who have received a pulmonary valve replacement for congenital heart disease at Children's Healthcare of Atlanta at Egleston or are in the Emory Healthcare System between 1976 and 2004.


Exclusion Criteria:


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 identifier (NCT number): NCT00276237

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United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Emory Healthcare System
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
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Principal Investigator: Paul M Kirshbom, MD Emory University Medical Center
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Responsible Party: Brian Kogon, Principal Investigator, Emory University Identifier: NCT00276237    
Other Study ID Numbers: 0668-2005
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by Brian Kogon, Emory University:
Congenital Heart Disease
Pulmonary Valve Replacement
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases