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NCT Number: NCT02097758

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

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.

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Key information

Conditions

Atrial Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Successful Device Closure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

Location status: Recruiting

Location contact

Jeong Yoon Jang, MD

SUB_INVESTIGATOR

Jong-Min Song, MD PhD

PRINCIPAL_INVESTIGATOR

Jong-Min Song, MD,PhD

CONTACT

[email protected]

+82-2-3010-3168

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcatheter device closure

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

Primary outcomes

  1. Successful device implantation

    Time frame: 1 day

Secondary outcomes

  1. Procedure time

    Time frame: during procedure

Other outcomes

  1. Complications from device

    Time frame: 1 year

    migration or dehiscence of device erosion cardiac rupture

Study contacts

Contact information is provided by the study sponsor or research team.

Jong-Min Song, MD,PhD

CONTACT

[email protected]

+82-2-3010-3168

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Acronym: ASD

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2014
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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