Occluder Size Determination in Transcatheter ASD II Closure Based on 3D TEE Assessment

Study Overview
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Brief Summary
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The aim of this study is to determine whether three-dimensional tranesophageal echocardiography (3D TEE) assessment of ostium secundum atrial septal defect (ASD II) may be as efficient as two-dimensional (2D) TEE assessment complemented by the balloon-sizing during transcatheter closure of the defect.

Detailed Description
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A total of 50 consecutive patients eligible to percutaneous ASD II closure will be enrolled in the study. 3D-TEE will be performed in the diagnostic process; the images will be recorded for further investigation, however, measurments of the defect will not be taken until after the procedure. Traditional 2D-TEE together with balloon-sizing assessment of the defect will be performed in enrolled patients in order to chose a device. Control transthoracic echocardiography (TTE) will be provided twice to evaluate the outcome of transcatheter treatment: 1 day after the procedure and 6-12 months later. The previously obtained 3D images will be retrospectively assessed by 2 independent investigators excluded from the interventionalists' team. Maximum and minimum diameter, perimeter and area of the defect will be measured to propose the assumed optimal occluder size. Correlation between proposed occluder size and the device used during the procedure will be statistically analyzed.

Official Title
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Occluder Size Determination in Transcatheter Closure of Ostium Secundum Atrial Septal Defect Based on Three-Dimensional Echocardiography Assessment

Conditions
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Ostium Secundum Atrial Septal Defect

Intervention / Treatment
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* Device: Transcatheter closure of ASD II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASD II suitable for percutaneous treatment free and informed consent to analyze the medical data of the person concerned age: patients over 16 Exclusion Criteria: ASD II not suitable for percutaneous treatment any valvular heart disease requiring cardiac surgery no free and informed consent to analyze the medical data of the person concerned age: under 16

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASD II<br>Transcatheter closure of ASD II | Device: Transcatheter closure of ASD II<br>* Transcatheter closure of ASD II performed in our center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the proposed and actual device size. | The correlation will be analyzed after the data of the whole group has been completed. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the procedure | Localization of the occluder in two echocardiographic assessments, 1 day and 6-12 months after the procedure. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASD II, transcatheter closure, percutaneous closure, 3D TEE, balloon-sizing