Lifetech Cera™ PFO 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 clinical use of the Lifetech Cera™ PFO 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 between 2019 to 2022. It is estimated to start enrollment in Sep 2023 and complete by end of 2024. Final report shall be completed in 2025.

Official Title
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A Real-world Registry Assessing the Clinical Use of the Lifetech Cera™ PFO Occluder

Conditions
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PFO, Patent Foramen Ovale

Intervention / Treatment
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* Device: The Cera™ PFO Occluder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO); Associated with TIA or cryptogenic stroke; Patients was implanted with the investigational device as per IFU instructions; Patients or legally authorized representatives have signed Data Release Consent or equivalent documents. Exclusion Criteria: Any contraindication mentioned in the corresponding IFU; 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 |
| --- | --- |
| PFO subjects<br>Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO) which is associated with TIA or cryptogenic stroke, and implanted with the investigational device. | Device: The Cera™ PFO Occluder<br>* The Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications | Serious procedure/device complications include device embolization, cardiac or vascular perforation, atrial fibrillation, device thrombosis, pulmonary embolism and deep vein thrombosis. | from attempted procedure to 24 months post-implantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful closure of the PFO, confirmed by contrast Transcranial Doppler (cTCD), defined as with no, small or moderate 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, Cera PFO, Occluder