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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFO subjects | Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO) which is associated with TIA or cryptogenic stroke, and implanted with the investigational device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Cera™ PFO Occluder | Device | The Cera™ PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of Patent Foramen Ovale (PFO). |
|
| 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO) which is associated with TIA or cryptogenic stroke, and implanted with the investigational device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oddział Kardiologii, Pracownia Hemodynamiki, Oddział Intensywnego Nadzoru Kardiologicznego oraz Pracownia Elektrofizjologii w Szpitalu w Myszkowie G.V.M.Carint | Myszków | Poland |
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| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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| 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 |
| 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 | Ustroń | Poland |
| Szpital Powiatowy im. dr Tytusa Chałubińskiego w Zakopanem | Zakopane | Poland |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |