Incidence of Neo-Aortic Insufficiency

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.

Study Overview

• Status: Terminated
• Conditions: Congenital Disorders

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 Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Kirk R Kanter, MD, Children's Healthcare of Atlanta

Study record dates

Study Major Dates

• Study Start: January 1, 2002

Study Registration Dates

• First Submitted: December 20, 2005
• First Submitted That Met QC Criteria: December 20, 2005
• First Posted (Estimate): December 22, 2005

Study Record Updates

• Last Update Posted (Estimate): May 7, 2007
• Last Update Submitted That Met QC Criteria: May 3, 2007
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: Pediatric; cardiac; neo-aortic insufficience; Norwood standard Stage I procedure; Norwood Sano procedure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: 05-067