Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276237
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2006-01-12
Brief Title:
Outcomes Following Pulmonary Valve Replacement in Adults
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Review of Outcomes Following Pulmonary Valve Replacement for Congenital Heart Disease in Adults
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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
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 Childrens 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None