Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384163
Status:
TERMINATED
Last Update Posted:
2013-11-26
First Post:
2006-10-03
Brief Title:
Adult Pulmonary Valve Replacement A Simple and Reproducible Technique
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Adult Pulmonary Valve Replacement A Simple and Reproducible Technique
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sufficient data collected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 atresiaventricular 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
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 222003 through and including March 222006 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
Primary Aim Present an effective technique for pulmonary valve replacement
Secondary Aim Present our excellent technical results of PVR in our adult congenital patients
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