Assessment of Right Ventricular Volume in Tetralogy of Fallott (TOF) Patients (VMS TOF)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Tetralogy of Fallott Following Repair; A Comparison Study to cMRI|
- The primary endpoint of this study is the percent difference between the VentriPoint Medical System (VMS) and cMRI for estimating the end diastolic and end systolic right ventricular volumes (EDV and ESV) in subjects following repair for TOF. [ Time Frame: 4 months ] [ Designated as safety issue: No ]The trial will be regarded as successful if it demonstrates the mean VMS-cMRI percent difference to be <10% and >-10% at a 1-sided 0.025 statistical significance level for each of EDV and ESV, with no safety concerns for the VMS procedure.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Imaging comparison study. No intervention.
Device: Ventripoint Medical System
The Knowledge Based Reconstruction (KBR) method generates a 3D reconstruction of the RV based on the Piecwise smooth subdivision surface method but without requiring manual border tracing. Instead KBR reconstructs a new patient's ventricular surface from the placement of anatomic landmark points on a 2D ultrasound image
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|United States, Pennsylvania|
|The Children's Hosptial of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|