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NCT02097758 Clinical Trial

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

Atrial Septal Defect Clinical Trial

— ASD  

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02097758
Other study ID # ASD_3D_device size
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date December 2024

Study information
Verified date January 2023
Source Asan Medical Center
Contact Jong-Min Song, MD,PhD
Phone +82-2-3010-3168
Email jmsong@amc.seoul.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Complications from device migration or dehiscence of device erosion cardiac rupture 1 year
Primary Successful device implantation 1 day
Secondary Procedure time during procedure
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