Percutaneous Closure of Atrial Septal Defects in Children: Integration of 3D Echocardiography and Fluoroscopy Imaging.
NCT ID: NCT02529111
Last Updated: 2018-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2015-12-31
2017-01-01
Brief Summary
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The aim of this study was to validate the image fusion in children.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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intervention
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.
"Echonavigator" software
Interventions
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"Echonavigator" software
Eligibility Criteria
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Inclusion Criteria
* 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
* ADS with minor shunt without indication of closure
* Refusal to participate in the study expressed by parental authority
18 Years
ALL
No
Sponsors
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Philips Healthcare
INDUSTRY
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Sébastien HASCOET, MD
Role: PRINCIPAL_INVESTIGATOR
UH Toulouse
Locations
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UH Toulouse
Toulouse, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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RC31/14/7415
Identifier Type: -
Identifier Source: org_study_id
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