Diagnosis of Coarctation of the Aorta and VSDNCT00327795
Surgical Outcomes in Pediatric Patients With Coarctation and VSD
An observational study of Diagnosis of Coarctation of the Aorta and VSD and Surgical Repair at CHOA, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diagnosis of Coarctation of the Aorta and VSD, Surgical Repair at CHOA, Between January 1, 2002 and December 31, 2005
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: diagnosis of coarctation and VSD
Who may be able to join
- diagnosis of coarctation and VSD
- surgical repair at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.
Who cannot join
- does not have coarctation and VSD
- did not have surgery at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Staged Approach to Coarctation and VSD Can Offer Optimal Outcomes
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.
- Conditions
- 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
- Medical subject headings
- Heart Septal Defects, Ventricular, Heart Defects, Congenital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startJan 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis of Coarctation of the Aorta and VSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Kirk R Kanter, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327795
- Sponsor's protocol ID
- 06-010
- Status last verified
- Jan 2006
- First submitted
- 18 May 2006
- Last updated
- 16 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staged Approach to Coarctation and VSD Can Offer Optimal Outcomes
- ClinicalTrials.gov ID
- NCT00327795
- Acronym / sponsor ID
- 06-010
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 32 participants
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- diagnosis of coarctation and VSD
Key inclusion criteria (2 listed)
- diagnosis of coarctation and VSD
- surgical repair at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.
Key exclusion criteria (2 listed)
- does not have coarctation and VSD
- did not have surgery at Children's Healthcare of Atlanta between January 1, 2002 and December 31, 2005.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk R Kanter, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis of Coarctation of the Aorta and VSD and Surgical Repair at CHOA, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012.