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

• Conditions: Ostium Secundum Atrial Septal Defect
• Interventions: Device: Transcatheter closure of ASD II

• Registration Number: NCT02601768
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-11
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-09
• Last Update Submitted: 2015-11-09
• Study First Posted: 2015-11-10
• Last Update Posted: 2015-11-10
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASD II	Transcatheter closure of ASD II	Transcatheter closure of ASD II

Primary Outcome Measures

Name	Time	Method
Correlation between the proposed and actual device size.	18 months	The correlation will be analyzed after the data of the whole group has been completed.

Secondary Outcome Measures

Name	Time	Method
Success rate of the procedure	12 months	Localization of the occluder in two echocardiographic assessments, 1 day and 6-12 months after the procedure.

Trial Locations

Locations (1)

Institute Of Cardiology; 🇵🇱 Warsaw, Poland