MedTrace Logo

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

NCT05529901 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-11-20

No results posted yet for this 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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2029-08-31
Completion
2029-08-31
FDA Device
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05529901 on ClinicalTrials.gov