NCT00277927

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1984

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1984

Completed
22 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 6, 2011

Status Verified

November 1, 2007

First QC Date

January 13, 2006

Last Update Submit

July 5, 2011

Conditions

Congenital Disorders

Keywords

PediatricCardiacValvar Pulmonary Stenosis

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesPulmonary Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • William T. Mahle, MD

    Children's Healthcare of Atlanta, Sibley Heart Center Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2006

First Posted

January 18, 2006

Study Start

January 1, 1984

Study Completion

December 1, 2007

Last Updated

July 6, 2011

Record last verified: 2007-11

Locations

US(1)