Clinical Trial: Percutaneous Closure of Atrial Septal Defects in Children: Integration of 3D Echocardiography and Fluoroscopy Imaging.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Integration of Three-dimensional Echocardiography and Fluoroscopy Imaging During the Percutaneous Closure of intAtrial Septal Defects in Children: CIA-3D-navigator.
Brief Summary:
The interventional catheterization allows the percutaneous treatment of congenital heart diseases as the atrial septal defect (ASD). The examination is guided by the X-rays with stochastic side effects worrying at the child's. The software "Echonavigator" allows to merge the ultrasound image and fluoroscopic. This innovative software facilitates the procedures and reduce the irradiation time in some adult procedures.
The aim of this study was to validate the image fusion in children.
Detailed Summary: The software "Echonavigator" will be used after the introduction of the percutaneous closure of ASD prosthesis. The image fusion on fluoroscopy will then be applied and the bias between the generated ultrasound image and the X-ray view of the prosthesis will be measured. The center marker visible prosthesis ultrasound and fluoroscopy used as a reference marker.
Sponsor: University Hospital, Toulouse
Current Primary Outcome: Validity of the image fusion. [ Time Frame: Day 1 ]
Through the fusion image will be measured by a fixed mark in 4 mm implications. This bias will be averaged in absolute terms and compared to zero through reference.
The bias will be measured by two methods: one using the tool positioning an echo point of interest later merged fluoroscopy, the other using a fusion of 3D image possible with the second version.
The method will be considered valid if the bias is not significantly different from 0 with a tolerance of 2 mm by 2 methods.
Original Primary Outcome: Same as current
Current Secondary Outcome: Feasibility assessed by the number and percentage (calculated with the 95% confidence interval) for procedures for which the image fusion of the prosthesis of CIA has been successfully obtained will be noted. [ Time Frame: Day1 ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Toulouse
Dates:
Date Received: August 18, 2015
Date Started: December 2015
Date Completion: December 2017
Last Updated: December 11, 2015
Last Verified: December 2015
