Congenital DisordersNCT00268073
Incidence of Neo-Aortic Insufficiency
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The records of all the patients that underwent the Norwood-Sano operation at Children's Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be investigated. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Congenital Disorders
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to not given
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients undergone Norwood-Sano at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004
- equal number of consecutive patients undergone Norwood classic stage I at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004
Who cannot join
- those who do not meet the inclusion criteria
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: Comparison of the Incidence of Neo-Aortic Insufficiency After Classic Norwood I and Norwood I-Sano Procedures
The records of all the patients that underwent the Norwood-Sano operation at Children's Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be investigated. These patients will be compared with an equal number of consecutive cases treated by classic Norwood stage I operation in order to determine the incidence of neo-aortic valve insufficiency and the clinical outcome of these patients.
Read the detailed description
Neoaortic valve insufficiency after Norwood type palliation of single ventricle patients has not been well studied. Patients with mild insufficiency tolerate it well; moderate to severe insufficiency however is poorly tolerated and can result in the death of the patient or at least require re-operation. Re-operation for neo-aortic insufficiency in this small size child is a difficult operation and the operative options are very limited. The introduction of the Sano modification of the Norwood procedure introduced a new set of variables due to the presence of a ventricular incision and possible distortion of the neo-aortic valve. It is therefore critical to determine the incidence of neo-aortic insufficiency and compare it to the standard Norwood operation, as well as to determine the clinical consequences of the presence of this phenomenon immediately postoperatively as well as long-term, up to completion of the stage II of the Norwood procedure (Glenn stage).
- Conditions
- Congenital Disorders
- Keywords
- Pediatric, cardiac, neo-aortic insufficience, Norwood standard Stage I procedure, Norwood Sano procedure
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies 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
- Defined population
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Kirk R Kanter, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268073
- Sponsor's protocol ID
- 05-067
- Status last verified
- May 2007
- First submitted
- 20 Dec 2005
- Last updated
- 7 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Incidence of Neo-Aortic Insufficiency After Classic Norwood I and Norwood I-Sano Procedures
- ClinicalTrials.gov ID
- NCT00268073
- Acronym / sponsor ID
- 05-067
- Conditions
- Congenital Disorders
- Keywords
- Pediatric, cardiac, neo-aortic insufficience, Norwood standard Stage I procedure, Norwood Sano procedure
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 2002
- First posted
- 22 Dec 2005 (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.
The records of all the patients that underwent the Norwood-Sano operation at Children's Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be investigated. These patients will be compared with an equal number of consecutive cases treated by classic Norwood stage I operation in order to determine the incidence of neo-aortic valve insufficiency and the clinical outcome of these patients.
Detailed description
Neoaortic valve insufficiency after Norwood type palliation of single ventricle patients has not been well studied. Patients with mild insufficiency tolerate it well; moderate to severe insufficiency however is poorly tolerated and can result in the death of the patient or at least require re-operation. Re-operation for neo-aortic insufficiency in this small size child is a difficult operation and the operative options are very limited. The introduction of the Sano modification of the Norwood procedure introduced a new set of variables due to the presence of a ventricular incision and possible distortion of the neo-aortic valve. It is therefore critical to determine the incidence of neo-aortic insufficiency and compare it to the standard Norwood operation, as well as to determine the clinical consequences of the presence of this phenomenon immediately postoperatively as well as long-term, up to completion of the stage II of the Norwood procedure (Glenn stage).
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients undergone Norwood-Sano at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004
- equal number of consecutive patients undergone Norwood classic stage I at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004
Key exclusion criteria (1 listed)
- those who do not meet the inclusion criteria
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 7 May 2007.
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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
Children's Healthcare of Atlanta
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 Congenital Disorders, 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 1 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 7 May 2007. 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 7 May 2007.