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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: Completed study of Tetralogy of Fallot, sponsored by VentriPoint Diagnostics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-08 |
What the finished NCT01419756 record still lists
NCT01419756 is an observational study that tracks outcomes without assigning an intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 174-participant average among 7 other Tetralogy of Fallot trials with a reported enrollment target (37% lower).
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 lists 6 locations in 5 states (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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