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NCT00268034 Clinical Trial

Left Ventricular Aneurysms in Children

Congenital Disorders Clinical Trial

Official title:
Left Ventricular Aneurysms in Children

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00268034
Other study ID # 04-073
Secondary ID
Status Terminated
Phase N/A
First received December 20, 2005
Last updated May 3, 2007
Start date June 2002

Study information
Verified date May 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- aneurysms between 6.30.2002 and 6.30.2004

Exclusion Criteria:

- those children who do no meet inclusion criteria

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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