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

Use our guide to learn which trials are right for you!

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
6
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
?
mi
from
Rochester, MN
Click here to add this to my saved trials