Atrial Septal Defects
Conditions
Keywords
Atrial Septal Defects (ASD), Percutaneous closure
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.
Interventions
DEVICEEchonavigator software
Sponsors
Philips Healthcare
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| 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. | Day 2 |
| Safety assessed by the heating degree of the ultrasound probe linked to the use of the software will be noted. | Day 1 |
Countries
France
Outcome results
None listed