Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique

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: NCT00384163
Recruitment Status : Terminated (sufficient data collected)
First Posted : October 5, 2006
Last Update Posted : November 26, 2013
Information provided by (Responsible Party):
Brian Kogon, Emory University

Brief Summary:
Pulmonary valve replacement in the adult population is an uncommon operation. The majority of native valve pathology in adults involves the mitral, aortic, and occasionally tricuspid valves. On the other hand, right ventricular outflow tract and pulmonary valve disease is quite common in children, especially with tetralogy of fallot, truncus arteriosus, pulmonary atresia/ventricular septal defect, and double outlet right ventricle. Unfortunately, right ventricular pathology often develops in adulthood as a result of pulmonary insufficiency or pulmonary stenosis created by previous childhood operations. Without the valve size constraints present at prior operations, these patients can be well-served by the placement of adult-sized bioprosthetic valves. There are limited descriptions in the adult cardiac literature of the actual technique of pulmonary valve replacement. We present our current technique and the pitfalls encountered when performing pulmonary valve replacement in adults.

Condition or disease
Congenital Disorders

Detailed Description:

This will be primarily a technique paper. The only clinical data points I am interested in are the presence of pulmonary stenosis, pulmonary insufficiency or perivalvular leak on the initial post-operative echocardiogram. I estimate reviewing 50 patients' charts dated March 22.2003 through and including March 22.2006 at Emory Hospital .

Primary Aim: Present an effective technique for pulmonary valve replacement

Secondary Aim: Present our excellent technical results of PVR in our adult congenital patients

Study Type : Observational
Enrollment : 50 participants
Time Perspective: Retrospective
Official Title: Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique
Study Start Date : August 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

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

Inclusion Criteria:

  • Adults undergoing pulmonary valve replacement
  • at Emory Hospital
  • between 3.22.03 amd 3.22.06

Exclusion Criteria:

  • those charts that do not fall under inclusion 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): NCT00384163

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30306
Sponsors and Collaborators
Emory University
Principal Investigator: Brian E Kogon, MD Emory University SOM

Responsible Party: Brian Kogon, Associate Professor of Surgery, Emory University Identifier: NCT00384163     History of Changes
Other Study ID Numbers: 0453-2006
First Posted: October 5, 2006    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013

Keywords provided by Brian Kogon, Emory University: