SVR Study Basics

SVR is the Trial of Right Ventricular vs. Modified Blalock-Taussig Shunt (MBTS) in Infants with Single Ventricle Defect Undergoing Staged Reconstruction. The short title for the study is Single Ventricle Reconstruction (SVR). Babies born with a single ventricle heart instead of the standard two ventricles, require a series of operations to correct. The first operation, the Norwood procedure , involves placing a shunt to carry blood from the heart to the lungs. This study was done to evaluate two commonly placed shunts to see which one would improve how patients do following the Norwood procedure. The study began on May 1, 2005 and the last infant was enrolled in June 2008 with 555 babies randomized.

Who was in the study?

Babies with a single ventricle (lower pumping chamber) heart instead of 2 ventricles were in the study if a Norwood procedure was planned.

What happened during the study?

Each qualified baby was randomly assigned to one of two groups, either the MBT shunt or the PA-to-RV shunt . Babies were followed until they reached 14 months of age, had an echocardiogram and a neurodevelopmental examination and perhaps a genetic evaluation .

What were the results of the study?

As of now, this study has finished enrolling patients but recently enrolled infants will still need to be followed for 14 months. It is anticipated that the follow-up will end in September 2009 and study results will follow.