Menu
Recruiting NCT02097758

Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect

No phase Interventional Atrial Septal Defect Successful Device Closure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter device closure.
Who it may be relevant to
Registry conditions: Atrial Septal Defect, Successful Device Closure. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is useful for evaluation of defect size and shape. The investigators suggested optimal device size using three-dimensional transesophageal echocardiographic image and our formula in previous study. Purpose: In this study, the investigators seek to predict the correct device size and confirm the accuracy of the formula that we made before device closure in ASD patients.

Interventions

  • Device Transcatheter device closure
    Closure of atrial septal defect with device * choosing device size with 3D image and the formula * we do not use sizing balloon for choosing of the device size

Primary outcome measures

  • Successful device implantation [Time frame: 1 day]
Secondary outcome measures (1)
  • Procedure time [Time frame: during procedure]

Eligibility criteria

Inclusion criteria

  • Age ≥18 year-old
  • Susceptible indication for atrial septal defect closure
  • Potential candidate for device closure

Exclusion criteria

  • Poor candidate for device closure: multiple ASDs, ect
  • Other heart disease requiring open heart surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Publications

  • Lee PH, Kim GY, Yu JS, Earm I, Kwon KB, Koo HI, Kim TO, Lee S, Sun BJ, Kim DH, Kang DH, Song JK, Song JM. Routine application of three-dimensional transesophageal echocardiography-based device selection for transcatheter closure of atrial septal defect without balloon sizing. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):905-912. doi: 10.1093/ehjci/jeag007. PMID 41530892
  • Jang JY, Heo R, Cho MS, Bae J, Hong JA, Lee S, Ahn JM, Park DW, Kim DH, Kang DH, Song JK, Song JM. Efficacy of 3D transoesophageal echocardiography for transcatheter device closure of atrial septal defect without balloon sizing. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):684-689. doi: 10.1093/ehjci/jex153. PMID 28633478

Identifiers

NCT: NCT02097758 · ASD_3D_device size

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗