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

Lifetech Scientific (Shenzhen) Co., Ltd.5 sites in 1 country94 target enrollmentAugust 22, 2023

ConditionsPatent Foramen Ovale PFO

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patent Foramen Ovale
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Enrollment: 94
Locations: 5
Primary Endpoint: Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 22, 2023

End Date

February 5, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: from attempted procedure to 24 months post-implantation.

Serious procedure/device complications include device embolization, cardiac or vascular perforation, atrial fibrillation, device thrombosis, pulmonary embolism and deep vein thrombosis.

Secondary Outcomes

Incidence of Device Deficiencies (DD)(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 death(from attempted procedure to 24 months post-implantation)
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 Serious Adverse Events (SAEs)(from attempted procedure to 24 months post-implantation)