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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- .
Secondary Endpoints
- Right
systolic and diastolic function
- Length of hospital
stay following
procedure
- Presence of
arrhythmias by 6 years
- Neurodevelopment,
behavior, health-related quality of life, and family function.
Inclusion Criteria
- Randomized
subject in the Single Ventricle Reconstruction Trial
- Informed consent
of parent(s) or legal guardian
Exclusion Criteria
- 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.
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Last updated: June 24, 2010 9:24 AM