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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

Recruiting · Not applicable · NCT03821129

Conditions: Stroke, PFO - Patent Foramen Ovale

At a glance

Research payments reported, 2025
$823,267
U.S. investigators named
41
Sites paid
39
Planned or actual enrollment
636

About the trial

Sponsor
W.L.Gore & Associates
Tested
PFO closure with GORE® CARDIOFORM Septal Occluder (device)
Dates
Started 2019-07-25; completion 2031-10
Results posted
Not yet

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.

From ClinicalTrials.gov, last updated 2026-07-30. Full record, eligibility and contacts (opens in a new tab)

Industry funding

W. L. Gore & Associates, Inc. reported $823,267 in research payments for this study in 2025 (233 payments).

Products named: Gore Cardioform Septal Occluder, Product in Development

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.