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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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