SVR Extension Study Basics

SVR II is an extension of the Trial of Right Ventricular vs. Modified Blalock-Taussig Shunt in Infants with Single Ventricle Defect Undergoing Staged Reconstruction. The target number is up to 270 children previously enrolled in the SVR study. The accrual period is approximately 8 years with recruitment to begin May 2008.

Study Design

A Follow-up of the SVR cohort

Primary Endpoint

Freedom from death and cardiac transplantation at 6 years post-randomization .

Secondary Endpoints

1. Right ventricular systolic and diastolic function
2. Length of hospital stay following Fontan procedure
3. Presence of arrhythmias by 6 years
4. Neurodevelopment, behavior, health-related quality of life, and family function.
   

Inclusion Criteria

1. Randomized subject in the Single Ventricle Reconstruction Trial
2. Informed consent of parent(s) or legal guardian
   

Exclusion Criteria

1. No patients enrolled in the original SVR Trial will be excluded from the primary endpoint, but those who undergo cardiac transplantation will be followed for vital status only.