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Incidence of Neo-Aortic Insufficiency

This study has been terminated.
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00268073
First received: December 20, 2005
Last updated: May 3, 2007
Last verified: May 2007
History of Changes
  Purpose

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.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Comparison of the Incidence of Neo-Aortic Insufficiency After Classic Norwood I and Norwood I-Sano Procedures

Resource links provided by NLM:

U.S. FDA Resources

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

Study Start Date: January 2002
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).

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • those who do not meet the inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268073

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 Children's Healthcare of Atlanta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00268073     History of Changes
Other Study ID Numbers: 05-067
Study First Received: December 20, 2005
Last Updated: May 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
Pediatric
cardiac
neo-aortic insufficience
Norwood standard Stage I procedure
Norwood Sano procedure

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013