ClinicalTrials.gg
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

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

Where this study stands

Counted across the records on this site · 2026-11-13

Among 18 studies in Heart Septal Defects, Ventricular with a site in United States — 1 open to participants now, 2 under way, none of them phase 3. Heart Septal Defects, Ventricular · United States.

Started
2006
the only one that year
Observational
4 of 18
none open now
Registered
4th of 18
by date
Lead sponsor
2 of 18
Children's Healthcare of Atlanta

Among the 18 studies in Heart Septal Defects, Ventricular with a site in United States, this one is the only one that started in 2006, is one of 4 observational ones, and was the 4th registered.

Heart Septal Defects, Ventricular

59 studies on the registry are indexed under Heart Septal Defects, Ventricular; 9 are open to participants now.

Browse Heart Septal Defects, Ventricular studies →

Open to participants now

1 of the 18 studies in Heart Septal Defects, Ventricular with a site in United States is open now. Recruiting first, the newest first:

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 6 Heart Septal Defects, Ventricular studies recruiting now, 2 set no upper age limit and 3 stop at 75 or younger; 4 take children under 18; none take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

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.

03

Conditions studied

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

Keywords

  • congenital heart disease
  • pediatric
  • surgical outcomes
04

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

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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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
32 participants
06

Study locations

1 site
  • Children's Healthcare of Atlanta
    Atlanta, Georgia 30322, United States
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2006 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2006
First posted
May 19, 2006
Start
Jan 2006
CompletionActual
Nov 2007
Last update
Mar 16, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

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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