Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Active, not recruiting

• Conditions: Cryptogenic Stroke; Stroke; PFO - Patent Foramen Ovale; TIA

• Registration Number: NCT05529901
• Lead Sponsor: W.L.Gore & Associates

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2022-10-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2029-08
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Conversion to surgical procedure	Discharge	Rate of post-procedure conversion to surgical procedure will be calculated.
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).
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.
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.
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.
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.

Trial Locations

Locations (1)

Okayama University Hospital; 🇯🇵 Okayama, Japan