NCT02601768

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: National Institute of Cardiology, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ostium Secundum Atrial Septal Defect

Interventions

Type	Name	Description
DEVICE	Transcatheter closure of ASD II	Transcatheter closure of ASD II performed in our center.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2015-11-10
• Last updated: 2015-11-10

Locations

1 site across 1 country: Poland