Back to results

Percutaneous Closure of Atrial Septal Defects in Children: Integration of 3D Echocardiography and Fluoroscopy Imaging. (CIA3DNAVIGATOR)

Primary Purpose

Atrial Septal Defects

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

"Echonavigator" software

About this trial

This is an interventional health services research trial for Atrial Septal Defects focused on measuring Atrial Septal Defects (ASD), Percutaneous closure

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UH Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02529111

First Posted

August 18, 2015

Last Updated

May 30, 2018

Sponsor

University Hospital, Toulouse

Collaborators

Philips Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT02529111

Brief Title

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

Acronym

CIA3DNAVIGATOR

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

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

December 2015 (Actual)

Primary Completion Date

January 1, 2017 (Actual)

Study Completion Date

January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

Collaborators

Philips Healthcare

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Septal Defects

Keywords

Atrial Septal Defects (ASD), Percutaneous closure

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intervention

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

"Echonavigator" software

Primary Outcome Measure Information:

Title

Validity of the image fusion.

Description

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

Time Frame

Day1

Other Pre-specified Outcome Measures:

Title

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.

Time Frame

Day 2

Title

Safety assessed by the heating degree of the ultrasound probe linked to the use of the software will be noted.

Time Frame

Day 1

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sébastien HASCOET, MD

Organizational Affiliation

UH Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

UH Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

13066260

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.

Results Reference

background

PubMed Identifier

4160716

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.

Results Reference

background

PubMed Identifier

6045537

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.

Results Reference

background

PubMed Identifier

946659

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.

Results Reference

background

PubMed Identifier

22041595

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs