Ostium Secundum Atrial Septal Defect
Conditions
Keywords
ASD II, transcatheter closure, percutaneous closure, 3D TEE, balloon-sizing
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.
Interventions
DEVICETranscatheter closure of ASD II
Transcatheter closure of ASD II performed in our center.
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Success rate of the procedure | 12 months | Localization of the occluder in two echocardiographic assessments, 1 day and 6-12 months after the procedure. |
Countries
Poland
Contacts
Primary ContactJan Henzel, MD
Backup ContactMarcin Demkow, Prof. MD PhD
Outcome results
None listed