Skip to main content
OpenTrials
Completed

NCT Number: NCT02529111

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Septal Defects Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Toulouse

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"Echonavigator" software

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. Safety assessed by the number and type of adverse effects associated with this technology will be noted on the day and the day after the procedure.

    Time frame: Day 2

  2. Safety assessed by the heating degree of the ultrasound probe linked to the use of the software will be noted.

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Philips Healthcare

Registry information

Official study title

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

Acronym: CIA3DNAVIGATOR

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 19, 2015
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.