Surgical Outcomes in Pediatric Patients With Coarctation and VSD

This study has been terminated.

Sponsor:

Information provided by:

Children's Healthcare of Atlanta

ClinicalTrials.gov Identifier:

NCT00327795

First received: May 18, 2006

Last updated: March 14, 2012

Last verified: January 2006

History of Changes

Purpose

Recently, a paper was published that compared outcomes of patients requiring repair of aortic coarctation and ventricular septal defect. Some surgeons opt to repair both defects in one surgery while other surgeons do the repair in two separate operations. Recently at Children's Healthcare of Atlanta, we have adopted the practice of correcting both defects during the same operation but through two separate incisions (one on the chest and the other through the ribs on the side. This reduces the amount of time the patient is on the heart-lung bypass machine during surgery. This study is a review of patient charts to compare outcomes of patients who have had surgery to repair their coarctation and VSD during 2002 through 2005.

Condition
Diagnosis of Coarctation of the Aorta and VSD Surgical Repair at CHOA Between January 1, 2002 and December 31, 2005

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Staged Approach to Coarctation and VSD Can Offer Optimal Outcomes

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

Estimated Enrollment:	32
Study Start Date:	January 2006
Study Completion Date:	November 2007

Detailed Description:

This study is a retrospective chart review of patients who carry the diagnosis of aortic coarctation and VSD and have had their surgical repair at Children's Healthcare of Atlanta between the dates of January 1, 2002 and December 31, 2005. The data collected will be surgical data such as type of repair, and the time the patient required cross clamp, circulatory arrest and cardiopulmonary bypass while in the operating room for the repair(s). We would also like to gather post-operative information such as time the patient required ventilation, whether they required a re-operation during the same admission, along with intensive care hours and hospital length of stay.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

diagnosis of coarctation and VSD

Criteria

Inclusion Criteria:

diagnosis of coarctation and VSD
surgical repair at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.

Exclusion Criteria:

does not have coarctation and VSD
did not have surgery at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327795

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:

Kirk R Kanter, MD

Emory University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00327795 History of Changes
Other Study ID Numbers:	06-010
Study First Received:	May 18, 2006
Last Updated:	March 14, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:

congenital heart disease
pediatric
surgical outcomes

Additional relevant MeSH terms:

Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities

Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 16, 2013

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