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Recruiting Not applicable Interventional

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

ClinicalTrials.gov ID: NCT03821129

Public ClinicalTrials.gov record NCT03821129. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 6, 2026, 8:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Study identification

NCT ID
NCT03821129
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
W.L.Gore & Associates
Industry
Enrollment
636 participants

Conditions and interventions

Interventions

  • PFO closure with GORE® CARDIOFORM Septal Occluder Device

Device

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 24, 2019
Primary completion
Sep 30, 2028
Completion
Sep 30, 2031
Last update posted
May 4, 2026

2019 – 2031

United States locations

U.S. sites
45
U.S. states
24
U.S. cities
42
Facility City State ZIP Site status
St. Mary's Hospital Tucson Arizona 85745 Withdrawn
Scripps Health La Jolla La Jolla California 92037 Recruiting
Loma Linda University Health Loma Linda California 92354 Recruiting
University of California - San Francisco San Francisco California 94143 Recruiting
Santa Barbara Cottage Hospital Santa Barbara California 93105 Recruiting
South Denver Cardiology Associates Littleton Colorado 80120 Recruiting
Medical Center of the Rockies Loveland Colorado 80538 Recruiting
Yale University School of Medicine New Haven Connecticut 06510 Recruiting
Baptist Health Jacksonville Jacksonville Florida 32207 Recruiting
Naples Community Hospital Naples Florida 34102 Recruiting
University of SF (Tampa General Hospital) Tampa Florida 33606 Recruiting
Cleveland Clinic Florida Weston Florida 33331 Active, not recruiting
Emory University Atlanta Georgia 30322 Active, not recruiting
Rush University Medical Center Chicago Illinois 60612 Recruiting
Alexian Brothers Medical Center Elk Grove Village Illinois 60007 Withdrawn
Northwestern University Evanston Illinois 60208 Recruiting
University of Iowa Hospitals & Clinic Iowa City Iowa 52242 Recruiting
Catholic Health Initiatives- Iowa Corp dba Iowa Heart West Des Moines Iowa 50266 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
University of Michigan Ann Arbor Michigan 48109 Recruiting
William Beaumont Hospital Royal Oak Michigan 48073 Withdrawn
Covenant Medical Center, Inc. Saginaw Michigan 48602 Terminated
University of Minnesota Edina Minnesota 55435 Withdrawn
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital Minneapolis Minnesota 55407 Recruiting
Jersey Shore University / Hackensack UMC Freehold New Jersey 07728 Recruiting
Research Foundation SUNY Buffalo Buffalo New York 14203 Recruiting
Columbia University Medical Center/NYPH New York New York 10032 Terminated
Atrium Health Charlotte North Carolina 28203 Recruiting
Providence Heart & Vascular Institute Portland Oregon 97225 Recruiting
Lehigh Valley Hospital Allentown Pennsylvania 18103 Recruiting
Medical University of South Carolina Charleston South Carolina 29425 Withdrawn
Tennova Healthcare Knoxville Tennessee 37934 Withdrawn
Vanderbilt University Medical Center Nashville Tennessee 37232 Terminated
Baylor College of Medicine-Houston Houston Texas 77030 Recruiting
The Methodist Hospital - Houston Houston Texas 77030 Recruiting
Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital San Antonio Texas 78229 Active, not recruiting
Baylor Scott & White Memorial Hospital Temple Texas 76508 Recruiting
St. Marks Hospital Salt Lake City Utah 84124 Recruiting
University of Utah Salt Lake City Utah 84132 Recruiting
University of Virginia Charlottesville Virginia 22908 Recruiting
Sentara Cardiovascular Research Institute Norfolk Virginia 23455 Terminated
Multicare Health Tacoma-Multicare Institute for Research & Innovation Tacoma Washington 98405 Recruiting
Charleston Area Medical Center (CAMC) Charleston West Virginia 25302 Recruiting
Aurora Health Care, Metro Inc. Milwaukee Wisconsin 53215 Recruiting
Medical College of Wisconsin, Inc. Milwaukee Wisconsin 53226 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03821129, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 4, 2026 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03821129 live on ClinicalTrials.gov.

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