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