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

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)

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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