Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229827
Status:
TERMINATED
Last Update Posted:
2012-03-16
First Post:
2005-09-13
Brief Title:
Optimal Timing for Repair of Left to Right Shunt Lesions
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Optimal Timing for Repair of Left-to-Right Shunt Lesions
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sufficient data was collected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals
Detailed Description:
In the past children with left-to-right shunt lesions such as ventricular septal defects and atrioventricular canal defects were palliated with a pulmonary artery band This prevented injury to the pulmonary vasculature while the child grew to a size where complete repair could be undertaken With the improvements in surgical technique and critical care there is a push to do a primary complete repair for these defects at younger and younger ages These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary heart failure and medication requirements The primary aim is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals The secondary aim is to define the criteria for failing medical anti-congestive heart failure therapy This study will be conducted through a retrospective chart review
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