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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary: 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.
Sponsor: Institute of Cardiology, Warsaw, Poland

Current Primary Outcome: Correlation between the proposed and actual device size. [ Time Frame: 18 months ]

The correlation will be analyzed after the data of the whole group has been completed.


Original Primary Outcome: Same as current

Current Secondary Outcome: Success rate of the procedure [ Time Frame: 12 months ]

Localization of the occluder in two echocardiographic assessments, 1 day and 6-12 months after the procedure.


Original Secondary Outcome: Same as current

Information By: Institute of Cardiology, Warsaw, Poland

Dates:
Date Received: November 9, 2015
Date Started: January 2015
Date Completion: December 2016
Last Updated: November 9, 2015
Last Verified: November 2015