Outcomes Following Pulmonary Valve Replacement in Adults

Heart Disease, Congenital Clinical Trial

Official title:

Review of Outcomes Following Pulmonary Valve Replacement for Congenital Heart Disease in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276237
• Other study ID #: 0668-2005
• Status: Completed
• Phase: N/A
• First received: January 12, 2006
• Last updated: November 25, 2013
• Start date: July 2005
• Est. completion date: November 2005

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Defects, Congenital
• Heart Disease, Congenital
• Heart Diseases
• Pulmonary Valve Replacement

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Emory Healthcare System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States,