Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique

Congenital Disorders Clinical Trial

Official title:

Adult Pulmonary Valve Replacement: A Simple and Reproducible Technique

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00384163
• Other study ID #: 0453-2006
• Status: Terminated
• Phase: N/A
• First received: October 3, 2006
• Last updated: November 25, 2013
• Start date: August 2007
• Est. completion date: August 2007

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Disorders

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States,