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

Not Applicable

Completed

• Conditions: Atrial Septal Defects
• Interventions: Device: "Echonavigator" software

• Registration Number: NCT02529111
• Lead Sponsor: University Hospital, Toulouse

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 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.

Study Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Study Start: 2015-12
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Weight higher than or equal to 20 kg
• Presence of an ostium secundum atrial septal defect diagnosed by transthoracic echocardiography and associated with a shunt from left to right evidenced by the significant dilation of the right cavities liable to a closure
• The ASD should have an anatomy allowing percutaneous closure according to international recommendations

Exclusion Criteria

• Children with contraindication to transesophageal ultrasound according to international recommendations
• ADS with minor shunt without indication of closure
• Refusal to participate in the study expressed by parental authority

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention	"Echonavigator" software	The "Echonavigator" software will be used on all patients. It will be used after the introduction of the percutaneous closure of ASD prosthesis. The image fusion on fluoroscopy will then be applied.

Primary Outcome Measures

Name	Time	Method
Validity of the image fusion.	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.

Secondary Outcome Measures

Name	Time	Method
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.	Day1

Trial Locations

Locations (1)

UH Toulouse; 🇫🇷 Toulouse, France