Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique

This study has been terminated.
(sufficient data collected)
Sponsor:
Information provided by (Responsible Party):
Brian Kogon, Emory University
ClinicalTrials.gov Identifier:
NCT00384163
First received: October 3, 2006
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique

Further study details as provided by Emory University:

Estimated Enrollment: 50
Study Start Date: August 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384163

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

No publications provided

Responsible Party: Brian Kogon, Associate Professor of Surgery, Emory University
ClinicalTrials.gov Identifier: NCT00384163     History of Changes
Other Study ID Numbers: 0453-2006
Study First Received: October 3, 2006
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
cardiac
adult
PVR

ClinicalTrials.gov processed this record on April 23, 2014