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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VentriPoint Diagnostics Ltd.
ClinicalTrials.gov Identifier:
NCT01419756
First received: August 16, 2011
Last updated: December 11, 2013
Last verified: July 2013
  Purpose

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 Intervention
Tetralogy of Fallot
Device: Ventripoint Medical System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by VentriPoint Diagnostics Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 109
Study Start Date: August 2011
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419756

Locations
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.
  More Information

No publications provided

Responsible Party: VentriPoint Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT01419756     History of Changes
Other Study ID Numbers: 2011041
Study First Received: August 16, 2011
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014