Atrial Septal DefectASDNCT02097758
Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
A study testing Transcatheter device closure in people with Atrial Septal Defect and Successful Device Closure, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Septal Defect, Successful Device Closure
- What is being tested?
- Transcatheter device closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 year-old
- Susceptible indication for atrial septal defect closure
- Potential candidate for device closure
Who cannot join
- Poor candidate for device closure: multiple ASDs, ect
- Other heart disease requiring open heart surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Jong-Min Song, MD,PhD, +82-2-3010-3168, jmsong@amc.seoul.kr
Jeong Yoon Jang, MD
About this study
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.
- Conditions
- Atrial Septal Defect, Successful Device Closure
- Being tested
- Transcatheter device closure
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter device closureDevice
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
| Study group | Role | What they receive |
|---|---|---|
| transcatheter device closure | Experimental | Choosing device size using three dimensional image and the formula without sizing balloon Receives: Device: Transcatheter device closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful device implantation
Measured: 1 day
Secondary outcomes (1)
Procedure time
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Septal DefectStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Min Song, Asan Medical Center
- Investigators
- Jong-Min Song, MD PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097758
- Sponsor's protocol ID
- ASD_3D_device size
- Acronym
- ASD
- Status last verified
- Jan 2023
- First submitted
- 25 Mar 2014
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 41530892Jang 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.
PubMed 28633478
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
- ClinicalTrials.gov ID
- NCT02097758
- Acronym / sponsor ID
- ASD / ASD_3D_device size
- Conditions
- Atrial Septal Defect, Successful Device Closure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transcatheter device closure | Experimental | Device: Transcatheter device closureChoosing device size using three dimensional image and the formula without sizing balloon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 year-old
- Susceptible indication for atrial septal defect closure
- Potential candidate for device closure
Key exclusion criteria (2 listed)
- Poor candidate for device closure: multiple ASDs, ect
- Other heart disease requiring open heart surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter device closureClosure 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 | Device | transcatheter device closure |
Primary outcome
Successful device implantation
Time frame: 1 day
1 secondary outcome
Procedure time
Time frame: during procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 41530892Lee 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.
- Derived from this study: PubMed 28633478Jang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jong-Min Song, MD PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter device closure in people with Atrial Septal Defect and Successful Device Closure, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jong-Min Song, MD,PhD (+82-2-3010-3168, jmsong@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful device implantation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02097758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.