Clinical Trial

GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

Study acronym: REDUCE PAS
Recruiting
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Summary
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
Protocol Amendment History 36 amendments
This ClinicalTrials.gov record has been amended 36 times since 2019-01-28; most recent amendment 2026-04-28.
Status change: Not Yet Recruiting → Recruiting 2019-04-26
Trial Details
NCT Number NCT03821129
Lead Sponsor W.L.Gore & Associates
Conditions Stroke, PFO - Patent Foramen Ovale
Enrollment 636 participants
Start Date 2019-07-25
Primary Completion 2028-10 (estimated)
Study Completion 2031-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-30