NCT02529111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

August 18, 2015

Last Update Submit

May 30, 2018

Conditions

Atrial Septal Defects

Keywords

Atrial Septal Defects (ASD)Percutaneous closure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Other Outcomes (2)

  • 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.

    Day 1

Study Arms (1)

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.

Device: "Echonavigator" software

Interventions

"Echonavigator" softwareDEVICE
intervention

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Toulouse

Toulouse, 31059, France

Location

Related Publications (5)

  • 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.

    PMID: 13066260BACKGROUND

  • 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.

    PMID: 4160716BACKGROUND

  • 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.

    PMID: 6045537BACKGROUND

  • 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.

    PMID: 946659BACKGROUND

  • 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.

    PMID: 22041595BACKGROUND

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sébastien HASCOET, MD

    UH Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 19, 2015

Study Start

December 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

June 1, 2018

Record last verified: 2018-05

Locations

FR(1)