Lifetech CeraFlex™ ASD Closure System 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 clinical use of the Lifetech CeraFlex™ Closure System 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 between 2019 and 2022. The data collection process is expected to complete by end of 2024. Final report shall be available in 2025.

Official Title
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A Multi-center, Single-arm, Real-world Registry Assessing the Clinical Use of the Lifetech CeraFlex™ ASD Closure System

Conditions
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Atrial Septal Defect

Intervention / Treatment
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* Device: CeraFlex™ Atrial Septal Defect (ASD) Closure System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device as per IFU instructions. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents. Exclusion Criteria: Patients did not conduct any follow up visit after hospital discharge.
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 |
| --- | --- |
| ASD subjects<br>Patients with a confirmed diagnosis of Atrial Septal Defect (ASD) and implanted with the investigational device. | Device: CeraFlex™ Atrial Septal Defect (ASD) Closure System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Procedural success is defined as a composite of: Absence of stroke/TIA, device embolization, cardiac or vascular perforation or device/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 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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Lifetech, Atrial Septal Defect, ASD, CeraFlex, ASD Closure System