NCT02529111

Percutaneous Closure of Atrial Septal Defects in Children: Integration of 3D Echocardiography and Fluoroscopy Imaging.

Integration of Three-dimensional Echocardiography and Fluoroscopy Imaging During the Percutaneous Closure of intAtrial Septal Defects in Children: CIA-3D-navigator.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Atrial Septal Defects

Interventions

Type	Name	Description
DEVICE	"Echonavigator" software

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2015-08-19
• Last updated: 2018-06-01

Locations

1 site across 1 country: France