Optimal Timing for Repair of Left to Right Shunt Lesions

March 14, 2012 updated by: Children's Healthcare of Atlanta

Optimal Timing for Repair of Left-to-Right Shunt Lesions

The purpose of this study is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals.

Study Overview

Status

Terminated

Conditions

Detailed Description

In the past, children with left-to-right shunt lesions such as ventricular septal defects and atrioventricular canal defects were palliated with a pulmonary artery band. This prevented injury to the pulmonary vasculature while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary heart failure and medication requirements. The primary aim is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals. The secondary aim is to define the criteria for failing medical anti-congestive heart failure therapy. This study will be conducted through a retrospective chart review.

Study Type

Observational

Enrollment

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta at Egleston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in the congenital surgery database

  • Patients who have undergone repair of ventricular septal defects
  • Patients who have undergone repair of atrioventricular canal defects

Description

Inclusion Criteria:

  • Patients in the congenital surgery database
  • Patients who have undergone repair of ventricular septal defects
  • Patients who have undergone repair of atrioventricular canal defects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Healthcare of Atlanta

Investigators

  • Principal Investigator: Brian Kogon, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 28, 2005

First Posted (Estimate)

September 30, 2005

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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