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NCT01419756 · ClinicalTrials.gov registry record

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

A clinical trial of Tetralogy of Fallot, sponsored by VentriPoint Diagnostics.

Completed
Registry status
109
Enrollment target
6
Study locations

NCT01419756 is a study of Tetralogy of Fallot that has completed, run by VentriPoint Diagnostics. The registered enrollment target is 109 participants, below the 174-participant average among 7 other Tetralogy of Fallot trials with a reported enrollment target (37% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT01419756, a study of Tetralogy of Fallot, has completed, sponsored by VentriPoint Diagnostics.

COMPLETED
Registry status
109 participants
Enrollment target
6
Study locations

Study 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 Studied

Tetralogy of Fallot

Interventions

  • DEVICE VentriPoint Medical System

Study Locations (6)

Ohio

  • Cleveland Clinic - Cleveland
  • Nationwide Children's Hospital - Columbus

Colorado

  • Children's Hospital Colorado - Aurora

Nebraska

  • University of Nebraska Medical Center - Omaha

Pennsylvania

  • The Children's Hosptial of Philadelphia - Philadelphia

Ontario

  • Hospital for Sick Children - Toronto

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2011-08
Est. Completion 2013-08

Sponsor

VentriPoint Diagnostics

2 total trials

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What the Registry Record Tells You About NCT01419756

The ClinicalTrials.gov registry entry for NCT01419756 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 174-participant average among 7 other Tetralogy of Fallot trials with a reported enrollment target (37% lower). The listed sponsor is VentriPoint Diagnostics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tetralogy of Fallot appearing as the primary indexed condition, and to 1 intervention - of which VentriPoint Medical System is the first listed.

NCT01419756 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Ohio, Colorado, Nebraska.

Frequently Asked Questions

What is clinical trial NCT01419756 about?

NCT01419756 is a clinical study titled "Assessment of Right Ventricular Volume in Tetralogy of Fallott (TOF) Patients". 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 patient...

What is the current status of trial NCT01419756?

This trial is currently completed. The enrollment target is 109 participants. The study started on 2011-08. Estimated completion is 2013-08.

What conditions does trial NCT01419756 study?

This clinical trial studies the following conditions: Tetralogy of Fallot.

What interventions are being tested in trial NCT01419756?

The interventions under investigation include: VentriPoint Medical System (DEVICE).

Who is sponsoring clinical trial NCT01419756?

This trial is sponsored by VentriPoint Diagnostics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01419756 being conducted?

This trial has 6 study locations across Colorado, Nebraska, Ohio, Pennsylvania, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.