Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00268034
Status:
TERMINATED
Last Update Posted:
2007-05-07
First Post:
2005-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Ventricular Aneurysms in Children
Sponsor:
Children's Healthcare of Atlanta
Organization:
Study Overview
Official Title:
Left Ventricular Aneurysms in Children
Status:
TERMINATED
Status Verified Date:
2007-05
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:
Collect data to support "standard of care possibility" of extracardiac repair with closure of intracavitary communication and plication of the aneurysm as probably safest surgical repair for left ventricular aneurysms.
Detailed Description:
Ventricular aneurysms in the pediatric population are rare and no standardized method of treatment exists.
We plan on reviewing five patient charts between the dates of 6.30.02 and 6.30.04 as to causes of aneurysms. The patient charts selected will be in the following "aneurysm categories":
Mostly occur after:
Ross/Ross-Konno procedures modified Rastelli-type interventricular tunnels repeated resections of subaortic stenosis and possibly after: myocardial ischemia trauma drainage of abscess in infective endocarditis progressive herniation of endocardium mostly located: in LV outflow tract
We plan on collecting echocardiograms and / or cardiac catheterizations data in order to confirm the diagnosis of an aneurysm. We will also collect the following information:
* Procedures including the dates performed
* Medications
* Physical Exam Findings
* Weight
* Gestational Age
* Outcome
We plan on reviewing five patient charts between the dates of 6.30.02 and 6.30.04 as to causes of aneurysms. The patient charts selected will be in the following "aneurysm categories":
Mostly occur after:
Ross/Ross-Konno procedures modified Rastelli-type interventricular tunnels repeated resections of subaortic stenosis and possibly after: myocardial ischemia trauma drainage of abscess in infective endocarditis progressive herniation of endocardium mostly located: in LV outflow tract
We plan on collecting echocardiograms and / or cardiac catheterizations data in order to confirm the diagnosis of an aneurysm. We will also collect the following information:
* Procedures including the dates performed
* Medications
* Physical Exam Findings
* Weight
* Gestational Age
* Outcome
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: