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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:5/27/2013
Start Date:August 2011

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Assessment of Right Ventricular Volume Using the Ventripoint Medical System in Patients With Tetralogy of Fallott Following Repair; A Comparison Study to cMRI


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.


Inclusion Criteria:

- Patients with Tetralogy of Fallot following surgical repair

- Patients who can be expected to lie motionless during imaging

Exclusion Criteria:

- 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
We found this trial at
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Philadelphia, Pennsylvania 19104
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9500 Euclid Avenue
Cleveland, Ohio 44106
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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Rochester, MN
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