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NCT00277927 Clinical Trial

Mild Valvar Pulmonary Stenosis

Congenital Disorders Clinical Trial

Official title:
Clinical Management of Children With Mild Valvar Pulmonary Stenosis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00277927
Other study ID # 04-035
Secondary ID
Status Terminated
Phase N/A
First received January 13, 2006
Last updated July 5, 2011
Start date January 1984
Est. completion date December 2007

Study information
Verified date November 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

Mild valvar pulmonary stenosis can be detected in 1/10,000 live births. Historical data suggested that most of these patients do well. Nonetheless, the majority of these patients is followed periodically by a pediatric cardiologist and may undergo repeated echocardiographic studies to follow the gradient. Such follow-up can be costly and it is not know if there is any benefit to periodic evaluation.

Description:

Young children (less than or equal to 2 years of age) with mild valvar pulmonary stenosis are unlikely to develop worsening stenosis with age and periodic cardiac evaluation is not warranted.

To describe the clinical course of children with mild valvar pulmonary stenosis diagnosed in early childhood. To examine the clinical practice patterns of cardiologists caring for these patients.

Retrospective chart review of all children diagnosed with mild valvar pulmonary stenosis born between 1984 and 2003 and followed by Sibley Heart Center Cardiology. Patient variables will include: pulmonary valve gradient, need for catheterization, exercise intolerance and endocarditis. Practice variables will include: frequency of follow-up, number of echocardiographic studies, exercise limitations.

Recruitment information / eligibility
Status Terminated
Enrollment 146
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 2 Years
Eligibility Inclusion Criteria:

- Children's Healthcare of Atlanta medical charts 1984 to 2003 diagnosed with mild valvar pulmonary stenosis Patients less than or equal to two years of age

Exclusion Criteria:

- Those who do no meet inclusion criteria

Study Design

Time Perspective: Retrospective

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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