GORE® CARDIOFORM Septal Occluder: 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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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 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.
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.
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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