Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
ASD
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 7, 2025
January 1, 2023
12.8 years
March 25, 2014
February 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Successful device implantation
1 day
Secondary Outcomes (1)
Procedure time
during procedure
Other Outcomes (1)
Complications from device
1 year
Study Arms (1)
transcatheter device closure
EXPERIMENTALChoosing device size using three dimensional image and the formula without sizing balloon
Interventions
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
Eligibility Criteria
You may qualify if:
- Age ≥18 year-old
- Susceptible indication for atrial septal defect closure
- Potential candidate for device closure
You may not qualify if:
- Poor candidate for device closure: multiple ASDs, ect
- Other heart disease requiring open heart surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
Related Publications (2)
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 Jan 13:jeag007. doi: 10.1093/ehjci/jeag007. Online ahead of print.
PMID: 41530892DERIVEDJang 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: 28633478DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong-Min Song, MD PhD
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 25, 2014
First Posted
March 27, 2014
Study Start
March 1, 2014
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 7, 2025
Record last verified: 2023-01