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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419756
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : October 6, 2014
Information provided by (Responsible Party):
VentriPoint Diagnostics Ltd.

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.

Condition or disease Intervention/treatment
Tetralogy of Fallot Device: VentriPoint Medical System

Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : August 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Single Arm
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

Primary Outcome Measures :
  1. 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 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic Cardiac Clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419756

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 Clinic
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
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
VentriPoint Diagnostics Ltd.

Responsible Party: VentriPoint Diagnostics Ltd. Identifier: NCT01419756     History of Changes
Other Study ID Numbers: 2011041
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: July 2013

Additional relevant MeSH terms:
Tetralogy of Fallot
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities