Clinical trial NCT02529111: Percutaneous Closure of Atrial Septal Defects in Children: Integration of 3D Echocardiography and Fluoroscopy Imaging.
Official title: Integration of Three-dimensional Echocardiography and Fluoroscopy Imaging During the Percutaneous Closure of intAtrial Septal Defects in Children: CIA-3D-navigator.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Septal Defects
Keywords: Atrial Septal Defects (ASD)
Percutaneous closure
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2015-08-19
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Validity of the image fusion.
timeFrame: Day 1
Secondary outcomes:
measure: 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.
timeFrame: Day1
Other outcomes:
measure: 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.
timeFrame: Day 2
measure: Safety assessed by the heating degree of the ultrasound probe linked to the use of the software will be noted.
timeFrame: Day 1
Locations:
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
affiliation: UH Toulouse
name: Sébastien HASCOET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: RUBIO-ALVAREZ V, LIMON R, SONI J. [Intracardiac valvulotomy by means of a catheter]. Arch Inst Cardiol Mex. 1953 Apr;23(2):183-92. No abstract available. Undetermined Language.
citation: Rashkind WJ, Miller WW. Creation of an atrial septal defect without thoracotomy. A palliative approach to complete transposition of the great arteries. JAMA. 1966 Jun 13;196(11):991-2. No abstract available.
citation: Porstmann W, Wierny L, Warnke H. Closure of persistent ductus arteriosus without thoracotomy. Ger Med Mon. 1967 Jun;12(6):259-61. No abstract available.
citation: King TD, Thompson SL, Steiner C, Mills NL. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA. 1976 Jun 7;235(23):2506-9.
citation: Van Aerschot I, Boudjemline Y. [Interventional cardiac catheterization in children]. Arch Pediatr. 2012 Jan;19(1):96-102. doi: 10.1016/j.arcped.2011.06.022. Epub 2011 Oct 29. French.