Optimal Timing for Repair of Left to Right Shunt Lesions

Ventricular Septal Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00229827
• Other study ID #: 05-092
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 14, 2012
• Start date: May 2005
• Est. completion date: August 2007

Study information

• Verified date: May 2007
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endocardial Cushion Defects
• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Mitral Valve Insufficiency
• Persistent Common Atrioventricular Canal
• Ventricular Septal Defects

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta at Egleston	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States,