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The objective of this PMCF study is to:
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| Measure | Description | Time Frame |
|---|---|---|
| Sizing success rate | The size of the selected occluder is proper by echocardiography observing | At procedure |
| Incidence of major adverse events (MAEs) | Major adverse events are defined as stroke, occluder embolization, arrhythmia, thromboembolic event, oversizing of the defect, cardiac tamponade, and other procedure and/or device-related complications requiring re-intervention. | From attempted procedure to discharge, up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Device success rate | Study device is successfully delivered in place and dilated without rupture and is successfully withdrew. | At procedure |
| Incidence of procedure and/or device-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with echocardiographic confirmation of a single secundum atrial septal defect (ASD) who are scheduled to undergo ASD closure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shen Yuanyuan | Contact | 86+18504356312 | shenyuanyuan@lifetechmed.com | |
| Fu Jiaxuan | Contact | 86 13973207184 | fujiaxuan@lifetechmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara (Bilkent) City Hospital | Recruiting | Ankara | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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Complications include vessel perforation/dissection, thromboembolism, hematoma, arrythmia, expansion of the defect, balloon migration, obstruction of venous return from the inferior vena cava.
| From attempted procedure to discharge, up to 14 days |
| Incidence of Serious Adverse Events | From attempted procedure to discharge, up to 14 days |
| Incidence of Device Deficiency (DD) | From attempted procedure to discharge, up to 14 days |
| Gazi Yasargil Woman and Child Hospital | Recruiting | Diyarbakır | Turkey (Türkiye) |
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| Gaziantep University Hospital | Not yet recruiting | Gaziantep | Turkey (Türkiye) |
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| SiyamiErsek Thoracic and Cardiovascular Surgery Training and Research Hospital | Not yet recruiting | Istanbul | Turkey (Türkiye) |
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| Tepecik Training and Research Hospital | Recruiting | Izmir | Turkey (Türkiye) |
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| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |