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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02097758
Acronym
ASD
Enrollment
100
Registered
2014-03-27
Start date
2014-03-31
Completion date
2026-12-31
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Septal Defect, Successful Device Closure

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.

Interventions

DEVICETranscatheter 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

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Successful device implantation1 day

Secondary

MeasureTime frame
Procedure timeduring procedure

Other

MeasureTime frameDescription
Complications from device1 yearmigration or dehiscence of device erosion cardiac rupture

Countries

South Korea

Contacts

Primary ContactJong-Min Song, MD,PhD
jmsong@amc.seoul.kr+82-2-3010-3168

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026