Assessment of Right Ventricular Volume in Tetralogy of Fallott (TOF) Patients

Assessment of Right Ventricular Volume using the VentriPoint Medical system in patients with
Tetralogy of Fallot following repair; a comparison study to cMRI.

The objective of this study is: To evaluate the accuracy of the VentriPoint Medical System
to calculate right ventricular volumes in patients with Tetralogy of Fallot following
surgical repair.

Secondary objectives are: To validate Inter and Intra observer variability at 3 clinical
sites.

The analyses will be the same for EDV and ESV. For either right ventricular volume, the
primary effectiveness measure is the % difference between VMS and cMRI results, i.e.
(VMS-cMRI)*100%/average of VMS and cMRI results. There will be two null hypotheses for the
primary analysis:

H0+: true mean % difference > 10% and H0-: true mean % difference < -10%

The observed mean % difference will be presented with 95% confidence intervals. The VMS
right ventricular volume estimates will be regarded as equivalent to cMRI estimates if both
H0+ and H0- are rejected at a 1-sided 0.025 level by a paired t test for both EDV and ESV.
Since H0+ and H0- cannot both be true, the total type I error rate for each measure is 0.025
and the overall type I error rate for both EDV and ESV is 0.05.