Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASD II | Transcatheter closure of ASD II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter closure of ASD II | Device | Transcatheter closure of ASD II performed in our center. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of the procedure | Localization of the occluder in two echocardiographic assessments, 1 day and 6-12 months after the procedure. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
50 consecutive adult patients with ASD II closed percutaneously in our center in the study time frame i.e.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Henzel, MD | Contact | 600699211 | +48 | jhenzel@ikard.pl |
| Marcin Demkow, Prof. MD PhD | Contact | mdemkow@ikard.pl |
| Name | Affiliation | Role |
|---|---|---|
| Jan Henzel, MD | Institute Of Cardiology in Warsaw | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute Of Cardiology | Recruiting | Warsaw | 04-628 | Poland |
Not provided
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |