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The objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.
The study intends to collect data from patients who have implanted with the device in 2019 or later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASD subjects | Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CeraFlex™ Atrial Septal Defect (ASD) Closure System | Device | The CeraFlex™ ASD Occluder have two types of occluders, CeraFlex™ ASD Occluder and CeraFlex™ Multi-fenestrated (Cribriform) ASD Occluder. The CeraFlex™ ASD Occluder is percutaneous, transcatheter closure devices for the non-surgical closure of atrial septal defects. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Procedural success is defined as a composite of:
| 6 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of moderate or large residual shunt | At procedure, 6 months and 12 months post-implantation | |
| Incidence of device or procedure related Adverse Events (AEs) | From attempted procedure to 24 months post-implantation |
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Inclusion Criteria:
Exclusion Criteria:
Patients did not conduct any follow up visit after hospital discharge.
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Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rae Gong | Contact | (86-755)-86026250-6957 | gongrui@lifetechmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pequeno Príncipe | Recruiting | Curitiba | Brazil |
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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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|
| Incidence of device or procedure related Serious Adverse Events (SAEs) | From attempted procedure to 24 months post-implantation |
| Incidence of Device Deficiencies (DD) | From attempted procedure to 24 months post-implantation |
| Incidence of death | From attempted procedure to 24 months post-implantation |
| Santa Casa de Misericórdia de Porto Alegre | Recruiting | Porto Alegre | Brazil |
|
| HCOR - Associação Beneficente Síria | Recruiting | São Paulo | Brazil |
|
| Hospital Beneficência Portuguesa | Recruiting | São Paulo | Brazil |
|
| Onassis Cardiac Surgery Center | Recruiting | Kallithea | Greece |
|
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |