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

Atrial Septal Defects Clinical Trial

— CIA3DNAVIGATOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02529111
• Other study ID #: RC31/14/7415
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: January 1, 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Septal Defects
• Heart Septal Defects
• Heart Septal Defects, Atrial

Intervention

Device:
• "Echonavigator" software

Locations

Country	Name	City	State
France	UH Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Philips Healthcare

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

Porstmann W, Wierny L, Warnke H. Closure of persistent ductus arteriosus without thoracotomy. Ger Med Mon. 1967 Jun;12(6):259-61. — View 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. — View 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. Undetermined Language. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Safety assessed by the heating degree of the ultrasound probe linked to the use of the software will be noted.		Day 1
Primary	Validity of the image fusion.	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.	Day 1
Secondary	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