Outcomes Following Pulmonary Valve Replacement in Adults

Completed

• Conditions: Heart Disease, Congenital; Pulmonary Valve Replacement

• Registration Number: NCT00276237
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study Completion: 2005-11
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Emory Healthcare System; 🇺🇸 Atlanta, Georgia, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States