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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05893758

Enrollment

Registered

2023-06-08

Start date

2023-08-10

Completion date

2024-02-01

Last updated

2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Foramen Ovale, PFO

Keywords

Lifetech, Cera PFO, Occluder

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.

Interventions

DEVICEThe Cera™ PFO Occluder

The Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO).

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO); 2. Associated with TIA or cryptogenic stroke; 3. Patients was implanted with the investigational device as per IFU instructions; 4. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.

Exclusion criteria

1. Any contraindication mentioned in the corresponding IFU; 2. Patients did not conduct any follow up visit after hospital discharge.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of stroke/TIA, procedure/device-related death and serious procedure/device complications	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

Measure	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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026