Single Ventricle (SVR) Extension Study Basics

The Single Ventricle Reconstruction Extension Study (SVR II) is a follow up study in the 555 babies who were previously enrolled into the Single Ventricle Reconstruction Trial (SVR Trial).

Study Design

A follow-up study of the 555 infants enrolled in the SVR trial.

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.