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TerminatedNCT00327795Updated Mar 16, 2012

Surgical Outcomes in Pediatric Patients With Coarctation and VSD

An observational study in Diagnosis of Coarctation of the Aorta and VSD, Surgical Repair at CHOA and Between January 1, 2002 and December 31, 2005, sponsored by Children's Healthcare of Atlanta. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2012-03-16.

Sponsored by Children's Healthcare of Atlanta · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
32
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

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

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Keywords

  • congenital heart disease
  • pediatric
  • surgical outcomes
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

diagnosis of coarctation and VSD

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

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.
04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
32 participants
05

Study locations

1 site
  • Children's Healthcare of Atlanta
    Atlanta, Georgia 30322, United States
06

Registry details

Key details

Study ID
NCT00327795
Lead sponsor
Children's Healthcare of Atlanta
First posted
May 19, 2006
Start date
Jan 2006
Completion
Nov 2007
Last update
Mar 16, 2012

Study contacts

Kirk R Kanter, MD
principal investigator · Emory University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.

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