Cera™ VSD Occluder Post Market Clinical Follow-up

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-center, Single Arm, Real-World Registry Assessing the Clinical Use of the Cera™ VSD Occluder

Conditions
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Ventricular Septal Defect

Intervention / Treatment
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* Device: Cera™ VSD occluder implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the investigational device as per IFU instructions Exclusion Criteria: Patients did not conduct any follow up visit after hospital discharge.

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VSD subjects<br>Patients with a confirmed diagnosis of Ventricular Septal Defect (VSD) and implanted with the Cera VSD occluder as per IFU instructions | Device: Cera™ VSD occluder implantation<br>* To collect data from patients who have implanted with the device before 2022.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Defined as a composite of: Absence of complete atrioventricular block (third degree AV block) needing pacemaker implantation, device embolization, severe aortic regurgitation requiring surgical repair or device or procedure related death, assessed at 6 months post-implantation. Successful closure of the defects, with no, trivial or small residual shunt confirmed by Doppler echocardiography at 6 months post-implantation . | 6 months post-implantation | 

Secondary Outcome Measures

| Outcome Measure | 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); |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cera VSD occluder, Observational, Retrospective, Multi-center