Active — Not RecruitingNot Applicable

Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Japan300 participantsStarted 2022-10-03

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PFO Closure Rate

Timeframe: 12 months

Rate of Conversion to surgical procedure

Timeframe: Discharge

Incidence rate of post-procedure ischemic stroke events

Timeframe: 36 months

Device success

Timeframe: 36 months

Incidence rate of post-procedure adverse events and/or device issues

Timeframe: 36 months

Incidence rate of device- and procedure-related events within 30 days post procedure

Timeframe: 30 days

Trial details

NCT IDNCT05529901

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-08

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