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

Lifetech Scientific (Shenzhen) Co., Ltd.94 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Patent Foramen Ovale PFO

Interventions

The Cera™ PFO OccluderDEVICE

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (5)

Oddział Kardiologii, Pracownia Hemodynamiki, Oddział Intensywnego Nadzoru Kardiologicznego oraz Pracownia Elektrofizjologii w Szpitalu w Myszkowie G.V.M.Carint

Myszków, Poland

Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii G.V.M.Carint-Oświęcim

Oświęcim, Poland

Polsko-Amerykańskie Kliniki Serca, Centrum Sercowo- Naczyniowe w Tychach, Grupa American Heart of Poland

Tychy, Poland

Polsko-Amerykańskie Kliniki Serca I Oddział Kardiologii Inwazyjnej i Niewydolności Serca w Ustroniu, Grupa AHoP

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Successful closure of the PFO, confirmed by contrast Transcranial Doppler (cTCD), defined as with no, small or moderate residual shunt

Time frame: at procedure, 6 months and 12 months post-implantation

Incidence of device or procedure related Adverse Events (AEs)

Time frame: from attempted procedure to 24 months post-implantation

Incidence of device or procedure related Serious Adverse Events (SAEs)

Time frame: from attempted procedure to 24 months post-implantation

Incidence of Device Deficiencies (DD)

Time frame: from attempted procedure to 24 months post-implantation

Incidence of death

Time frame: from attempted procedure to 24 months post-implantation

Data from ClinicalTrials.gov

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