Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

N/AActive Not RecruitingNCT05529901

W.L.Gore & Associates300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Stroke PFO - Patent Foramen Ovale Cryptogenic Stroke TIA

Interventions

GORE® CARDIOFORM Septal OccluderDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Okayama University Hospital

Okayama, Japan

Outcomes

Primary Outcomes

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).

Time frame: 12 months

Rate of Conversion to surgical procedure

Rate of post-procedure conversion to surgical procedure will be calculated.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 30 days

Data from ClinicalTrials.gov

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