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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Echonavigator" software | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 |
| Measure | Description | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sébastien HASCOET, MD | UH Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Toulouse | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13066260 | Background | 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. | |
| 4160716 | Background | 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. |
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| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| Day 1 |
| 6045537 | Background | 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. |
| 946659 | Background | 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. |
| 22041595 | Background | 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. |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |