Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Stroke Clinical Trial

— GSO-PFO PMS  

Official title:

Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05529901
• Other study ID #: JPS 21-08
• Status: Recruiting
• Start date: October 3, 2022
• Est. completion date: May 2031

Study information

• Verified date: July 2023
• Source: W.L.Gore & Associates
• Contact: Masaru Ohara
• Phone: 81 70 1596 0480
• Email: maohara[@]wlgore.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2031
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryptogenic Stroke
• Foramen Ovale, Patent
• Ischemic Stroke
• PFO - Patent Foramen Ovale
• Stroke
• TIA

Intervention

Device:
• 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

Locations

Country	Name	City	State
Japan	Okayama University Hospital	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence rate of post-procedure Atrial fibrillation	Rate of post-procedure AF will be calculated during each follow-up period.	36 months
Primary	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
Primary	Rate of Conversion to surgical procedure	Rate of post-procedure conversion to surgical procedure will be calculated.	Discharge
Primary	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
Primary	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
Primary	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
Primary	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