Mild Valvar Pulmonary Stenosis

This study has been terminated.
(sufficient data collected for significant study results)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00277927
First received: January 13, 2006
Last updated: July 5, 2011
Last verified: November 2007
  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

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: William T Mahle, MD, Children's healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00277927     History of Changes
Other Study ID Numbers: 04-035
Study First Received: January 13, 2006
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014