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Mild Valvar Pulmonary Stenosis

This study has been terminated.
(sufficient data collected for significant study results)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00277927
First Posted: January 18, 2006
Last Update Posted: July 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Healthcare of Atlanta
  Purpose
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.

Condition
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Clinical Management of Children With Mild Valvar Pulmonary Stenosis

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 146
Study Start Date: January 1984
Study Completion Date: December 2007
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children at Children's Healthecare of Atlanta between the dates of 1984 and 2003 with mild valvar pulmonary stenosis that were less than 2 years old
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277927


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: William T. Mahle, MD Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
  More Information

Responsible Party: William T Mahle, MD, Children's healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00277927     History of Changes
Other Study ID Numbers: 04-035
First Submitted: January 13, 2006
First Posted: January 18, 2006
Last Update Posted: July 6, 2011
Last Verified: November 2007

Keywords provided by Children's Healthcare of Atlanta:
Pediatric
Cardiac
Valvar Pulmonary Stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Pulmonary Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction