Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAsan Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 year-old
Susceptible indication for atrial septal defect closure
Potential candidate for device closure
Disqualifiers
Poor candidate for device closure: multiple ASDs, ect
Other heart disease requiring open heart surgery
Trial design
Design model
Single group
Treatments tested in this trial
Transcatheter device closure
DeviceClosure 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
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: transcatheter device closureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Successful device implantation
Time frame
1 daySecondary outcomes
1
Procedure time
Time frame
during procedureOther outcomes
1
Complications from device
migration or dehiscence of device erosion cardiac rupture
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov