Status:

COMPLETED

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

Lead Sponsor:

VentriPoint Diagnostics Ltd.

Conditions:

Tetralogy of Fallot

Eligibility:

All Genders

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 evalu...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 1 2013

Estimated Enrollment :

109 Patients enrolled

Trial Details

Trial ID

NCT01419756

Start Date

August 1 2011

End Date

August 1 2013

Last Update

October 6 2014

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

2

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

3

Cleveland Clinic

Cleveland, Ohio, United States, 44195

4

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205