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The objective of this study is to evaluate the effectiveness and the safety of the intracardiac septal closure device (CBO), as well as the practicability of implantation of this device using the accessories (DS for CBO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Closure of Atrial Septal Defect | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device Closure of Atrial Septal Defect | Device | Device Closure of Atrial Septal Defect by "Carag Bioresorbable Septal Occluder" |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective closure of defect | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Horst Sievert, Prof. Dr. | CardioVaskuläres Centrum Frankfurt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CardioVaskuläres Centrum | Frankfurt | Germany |
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| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |