Cryptogenic Stroke, PFO - Patent Foramen Ovale, Stroke, TIA
Conditions
Brief summary
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.
Interventions
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
Sponsors
W.L.Gore & Associates
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings) * Diagnosed with a PFO * Note: Additional Inclusion Criteria may apply
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of post-procedure ischemic stroke events | 36 months | Incidence rate of post-procedure ischemic stroke will be calculated. Additionally, those stroke events will be evaluated by Kapan-Meier plot. |
| PFO Closure Rate | 12 months | 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). |
| Rate of Conversion to surgical procedure | Discharge | Rate of post-procedure conversion to surgical procedure will be calculated. |
| Incidence rate of device- and procedure-related events within 30 days post procedure | 30 days | 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. |
| Device success | 36 months | 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. |
| Incidence rate of post-procedure adverse events and/or device issues | 36 months | Incidence rate of adverse events and/or device issues collected through each follow-up period will be calculated. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of post-procedure Atrial fibrillation | 36 months | Rate of post-procedure AF will be calculated during each follow-up period. |
Countries
Japan
Outcome results
None listed