Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446108
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2007-03-09
Brief Title:
Retrospective Pulmonary Valve Replacement Imaging
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Proposal for Retrospective Review of Imaging Pre- and Post - Pulmonary Valve Replacement
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:
This is a retrospective chart review examining children and adults with history of Tetralogy of Fallot or pulmonary stenosis who have undergone subsequent pulmonary valve replacement The primary interest of the study is to analyze the routine pre- and post-operative imaging studies
Detailed Description:
Congenital heart defects having a component of pulmonary stenosis narrowing are often palliated in childhood by disrupting the pulmonary valve This arrangement can provide an excellent quality of life as these children grow and enter young adulthood Unfortunately the pulmonary insufficiency that is created by disrupting the pulmonary valve results in volume overload of the right heart This may eventually lead to right ventricular dilation and irreversible right heart failure In addition volume load of the right heart may affect the inter-ventricular septum and left heart function as well Placement of a competent pulmonary valve at a subsequent operation hopefully at a time without the replacement valve size constraints present at the initial operation is a means to eliminate the volume overload and prevent these further sequelae
Unfortunately the optimal timing for subsequent pulmonary valve replacement is controversial One of the currently used indications for valve replacement includes a right ventricular to left ventricular volume ratio greater than two However determining the boundaries of the right ventricle by echocardiography and magnetic resonance imaging is difficult in the absence of a pulmonary valve The boundaries are determined by an arbitrary estimation of where the pulmonary valve should be Other potential indicators for pulmonary valve replacement may be right ventricular area and right ventricular strain determined by echocardiography These measurements are not affected by the absence of the pulmonary valve They may provide better markers for impending right ventricular failure and a simpler means to follow serial improvement following valve replacement
While the emphasis after pulmonary valve disruption typically lies on the right ventricle there is evidence that the left ventricle may become impaired as well Volume load on the right ventricle causes bowing of the inter-ventricular septum and affects left ventricular function Echocardiographic imaging of the left ventricle may also be important to follow serial improvement of the left heart following pulmonary valve replacement
All charts reviewed will be of patients who had their surgery at Childrens Healthcare of Atlanta or Emory University Hospital between January 1 1994 and December 31 2006 We will review approximately 125 patients charts for patients between the ages of 1 and 65 years of age who have required pulmonary valve replacement
Unfortunately the optimal timing for subsequent pulmonary valve replacement is controversial One of the currently used indications for valve replacement includes a right ventricular to left ventricular volume ratio greater than two However determining the boundaries of the right ventricle by echocardiography and magnetic resonance imaging is difficult in the absence of a pulmonary valve The boundaries are determined by an arbitrary estimation of where the pulmonary valve should be Other potential indicators for pulmonary valve replacement may be right ventricular area and right ventricular strain determined by echocardiography These measurements are not affected by the absence of the pulmonary valve They may provide better markers for impending right ventricular failure and a simpler means to follow serial improvement following valve replacement
While the emphasis after pulmonary valve disruption typically lies on the right ventricle there is evidence that the left ventricle may become impaired as well Volume load on the right ventricle causes bowing of the inter-ventricular septum and affects left ventricular function Echocardiographic imaging of the left ventricle may also be important to follow serial improvement of the left heart following pulmonary valve replacement
All charts reviewed will be of patients who had their surgery at Childrens Healthcare of Atlanta or Emory University Hospital between January 1 1994 and December 31 2006 We will review approximately 125 patients charts for patients between the ages of 1 and 65 years of age who have required pulmonary valve replacement
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