Clinical trial NCT01419756: Assessment of Right Ventricular Volume in Tetralogy of Fallott (TOF) Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tetralogy of Fallot
Lead sponsor: VentriPoint Diagnostics Ltd.
Sponsor class: INDUSTRY
First posted: 2011-08-18
Enrollment: 109
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic Cardiac Clinic

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hosptial of Philadelphia
state: Pennsylvania
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
References: