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The objective of this post-market registry is to assess the safety and performance of the Lifetech Cera™ VSD occluder in a real-world and on-label fashion.
The study intends to collect data from patients who have implanted with the device before 2022. The study is expected to completed by the end of 2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSD subjects | Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the Cera VSD occluder as per IFU instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cera™ VSD occluder implantation | Device | To collect data from patients who have implanted with the device before 2022. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | 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 new onset complete AV block (third-degree AV block) or any new onset arrhythmia needing for pacemaker implantation, or new onset left bundle branch block (LBBB); |
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Inclusion Criteria:
Exclusion Criteria:
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The study intends to collect data from patients who have implanted with the device before 2022
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| Name | Affiliation | Role |
|---|---|---|
| Jou-Kou Wang | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan | ||||
| Kaohsiung Veterans General Hospital |
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| ID | Term |
|---|---|
| D006345 | Heart Septal Defects, Ventricular |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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| from attempted procedure to 24 months post-implantation |
| Incidence of new onset second-degree AV block | from attempted procedure to 24 months post-implantation |
| Incidence of new onset severe aortic or tricuspid regurgitation | from attempted procedure to 24 months post-implantation |
| Incidence of device-related thrombosis (DRT) | from attempted procedure to 24 months post-implantation |
| Incidence of device embolization | from attempted procedure to 24 months post-implantation |
| Incidence of device or procedure related Adverse Events (AEs) | from attempted procedure to 24 months post-implantation |
| 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 |
| Kaohsiung City |
| Taiwan |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Mackay Memorial Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Linkou Chang-Gung Memorial Hospita | Taoyuan | Taiwan |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |