Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® CARDIOFORM Septal Occluder | Device | Patients for whom the device is used (implanted or used by not implanted) during the enrollment period of this post-marketing surveillance will be considered eligible for the study |
| Measure | Description | Time Frame |
|---|---|---|
| PFO Closure Rate | PFO closure success will be defined as the number of cases which achieve effective PFO closure at 12 months post-initial procedure out of those which complete the PFO closure evaluation under Trans-Thoracic Echocardiography (TTE) with bubbles. PFO effective closure will be defined as the number of bubbles confirmed to be less than 20 (<20). | 12 months |
| Rate of Conversion to surgical procedure | Rate of post-procedure conversion to surgical procedure will be calculated. | Discharge |
| Incidence rate of post-procedure ischemic stroke events | Incidence rate of post-procedure ischemic stroke will be calculated. Additionally, those stroke events will be evaluated by Kapan-Meier plot. | 36 months |
| Device success | Device success will be calculated by the number of cases with successful device implant during the initial procedure and later follow-ups out of those which underwent the transcatheter PFO closure procedure. | 36 months |
| Incidence rate of post-procedure adverse events and/or device issues | Incidence rate of adverse events and/or device issues collected through each follow-up period will be calculated. | 36 months |
| Incidence rate of device- and procedure-related events within 30 days post procedure | Incidence rate of adverse events and/or device issues which are defined as device- or procedure-related within 30 days post procedure will be calculated. | 30 days |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of post-procedure Atrial fibrillation | Rate of post-procedure AF will be calculated during each follow-up period. | 36 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients who have had a cryptogenic stroke (including transient ischemic attack with positive head imaging findings) with possible involvement of patent foramen ovale (PFO) due to a presumed paradoxical embolism.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Okayama University Hospital | Okayama | 700-8558 | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D054092 | Foramen Ovale, Patent |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |