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

Completed

Conditions studied: Tetralogy of Fallot

In brief

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.

Key facts

Study ID

NCT01419756

Run by

VentriPoint Diagnostics Ltd.

People needed

109

Starts

2011-08-01

Expected to finish

2013-08-01

Last updated by the study team

2014-10-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Tetralogy of Fallot following surgical repair
• Patients who can be expected to lie motionless during imaging

You may not qualify if…

• Lack of informed consent
• Surgical repair for Tetralogy of Fallot with RV-PA conduit
• Known arrhythmia that interferes with image acquisition.
• Implanted cardiac defibrillator, pacemaker, or other devices containing ferromagnetic materials
• Pregnant woman
• Contraindications for MRI

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• The Children's Hosptial of Philadelphia — Philadelphia, Pennsylvania, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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