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

A

Asan Medical Center

Status

Enrolling

Conditions

Atrial Septal Defect
Successful Device Closure

Treatments

Device: Transcatheter device closure

Study type

Interventional

Funder types

Other

Identifiers

NCT02097758
ASD_3D_device size

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

transcatheter device closure
Experimental group
Description:
Choosing device size using three dimensional image and the formula without sizing balloon
Treatment:
Device: Transcatheter device closure

Trial contacts and locations

1

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Central trial contact

Jong-Min Song, MD,PhD

Data sourced from clinicaltrials.gov

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