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

NCT01419756 | Completed

• 1 other identifier: 2011041
• Study Type: observational
• Target: 109
• Locations: 2 countries
• Sites: 6

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.

Conditions

Tetralogy of Fallot

Outcome Measures

Primary Outcomes (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.

  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.

  4 months

Study Arms (1)

Single Arm

Imaging comparison study. No intervention.

Device: VentriPoint Medical System

Interventions

VentriPoint Medical System DEVICE

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

Single Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic Cardiac Clinic

You may qualify if:

• Patients with Tetralogy of Fallot following surgical repair
• Patients who can be expected to lie motionless during imaging

You may not qualify if:

• 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

Sponsors & Collaborators

• VentriPoint Diagnostics Ltd.: lead

Study Sites (6)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Children's Hosptial of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Tetralogy of Fallot

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 18, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 6, 2014

Record last verified: 2013-07

Locations

US (5); CA (1)