Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

NCT05529901 | Active Not Recruiting FDA Device

• 1 other identifier: JPS 21-08
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; PFO - Patent Foramen Ovale; Cryptogenic Stroke; TIA

Outcome Measures

Primary Outcomes (6)

• 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

• Rate of Conversion to surgical procedure

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

  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.

  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.

  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.

  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.

  30 days

Other Outcomes (1)

• Incidence rate of post-procedure Atrial fibrillation

  36 months

Interventions

GORE® CARDIOFORM Septal Occluder DEVICE

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 Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have had a cryptogenic stroke (including transient ischemic attack with positive head imaging findings) with possible involvement of patent foramen ovale (PFO) due to a presumed paradoxical embolism.

You may qualify if:

• Diagnosed with cryptogenic stroke (including transient ischemic attack with positive head imaging findings)
• Diagnosed with a PFO

You may not qualify if:

• N/A

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

Okayama University Hospital

Okayama, 700-8558, Japan

Location

MeSH Terms

Conditions

Stroke; Foramen Ovale, Patent; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 7, 2022
• Study Start: October 3, 2022
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)