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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tetralogy of Fallot

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Arm

Imaging comparison study. No intervention.

VentriPoint Medical System

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No