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

NCT ID: NCT02097758

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Septal Defect Successful Device Closure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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transcatheter device closure

Choosing device size using three dimensional image and the formula without sizing balloon

Group Type EXPERIMENTAL

Transcatheter device closure

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong-Min Song

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong-Min Song, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jong-Min Song, MD,PhD

Role: CONTACT

+82-2-3010-3168

Facility Contacts

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Jong-Min Song, MD,PhD

Role: primary

+82-2-3010-3168

References

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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.

Reference Type DERIVED
PMID: 28633478 (View on PubMed)

Other Identifiers

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ASD_3D_device size

Identifier Type: -

Identifier Source: org_study_id

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