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

Ostium Secundum Atrial Septal Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02601768
• Other study ID #: 2.11/VI/15
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2015
• Last updated: November 9, 2015
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Jan Henzel, MD
• Phone: 600699211
• Email: jhenzel[@]ikard.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Heart Septal Defects
• Heart Septal Defects, Atrial
• Ostium Secundum Atrial Septal Defect

Intervention

Device:
• Transcatheter closure of ASD II
Transcatheter closure of ASD II performed in our center.

Locations

Country	Name	City	State
Poland	Institute Of Cardiology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Success rate of the procedure	Localization of the occluder in two echocardiographic assessments, 1 day and 6-12 months after the procedure.	12 months	No