Actively Recruiting
Led by Asan Medical Center · Updated on 2025-02-07
100
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying the use of three-dimensional transesophageal echocardiography to select the correct device size for closing atrial septal defects (ASD) without using a sizing balloon. The study aims to confirm the accuracy of a previously developed formula for device size prediction and improve the procedure for ASD patients. This research is sponsored by Asan Medical Center and focuses on patients aged 18 to 80 who are candidates for device closure. Participants undergo transcatheter device closure where the device size is chosen using the three-dimensional echocardiographic images combined with the formula, avoiding the use of a sizing balloon. This method is being evaluated for its effectiveness in ensuring successful device implantation during the procedure. During the study, researchers will measure the success of device implantation within one day after the procedure and record procedure time. Participants will be monitored closely to assess outcomes related to the device closure process. The study started in March 2014 and is expected to continue until December 2026, involving adult patients who meet the eligibility criteria.
CONDITIONS
Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day
Participants undergo transcatheter device closure of the atrial septal defect using three-dimensional imaging to select device size without a sizing balloon.
1 procedure visit (in-person)
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 138-736
Actively Recruiting
J
Jong-Min Song, MD,PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Pil Hyung Lee, Ga Yun Kim, Jae Sung Yu...
https://pubmed.ncbi.nlm.nih.gov/41530892Jeong Yoon Jang, Ran Heo, Min Soo Cho...
https://pubmed.ncbi.nlm.nih.gov/28633478