Lifetech Cera™ PFO Occluder Post-Market Clinical Follow-Up

Completed

• Conditions: Patent Foramen Ovale; PFO

• Registration Number: NCT05893758
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-30
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO);<br><br> 2. Associated with TIA or cryptogenic stroke;<br><br> 3. Patients was implanted with the investigational device as per IFU instructions;<br><br> 4. Patients or legally authorized representatives have signed Data Release Consent or<br> equivalent documents.<br><br>Exclusion Criteria:<br><br> 1. Any contraindication mentioned in the corresponding IFU;<br><br> 2. Patients did not conduct any follow up visit after hospital discharge.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications

Secondary Outcome Measures

Name	Time	Method
Successful closure of the PFO, confirmed by contrast Transcranial Doppler (cTCD), defined as with no, small or moderate residual shunt;Incidence of device or procedure related Adverse Events (AEs);Incidence of device or procedure related Serious Adverse Events (SAEs);Incidence of Device Deficiencies (DD);Incidence of death