Optimal Timing for Repair of Left to Right Shunt Lesions

This study has been terminated.
(sufficient data was collected)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00229827
First received: September 13, 2005
Last updated: March 14, 2012
Last verified: May 2007
  Purpose

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.


Condition
Ventricular Septal Defects
Persistent Common Atrioventricular Canal

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Optimal Timing for Repair of Left-to-Right Shunt Lesions

Resource links provided by NLM:


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

Estimated Enrollment: 200
Study Start Date: May 2005
Study Completion Date: August 2007
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229827

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Brian Kogon, MD Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00229827     History of Changes
Other Study ID Numbers: 05-092
Study First Received: September 13, 2005
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Healthcare of Atlanta:
pediatric health
cardiac
pediatric population
congenital heart surgery
left to right shunt lesions
heart surgery
Atrioventricular canal defects

Additional relevant MeSH terms:
Endocardial Cushion Defects
Heart Septal Defects
Heart Septal Defects, Ventricular
Mitral Valve Insufficiency
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on October 23, 2014