Clinical trialNCT03821129RecruitingInterventional

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

SponsorW.L.Gore & AssociatesEnrollment636PFO - Patent Foramen OvaleStroke

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

45 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

St. Mary'S Hospital
Tucson, Arizona, United States
Withdrawn
Scripps Health la Jolla
La Jolla, California, United States
Matthew Price, MD
Recruiting
Loma Linda University Health
Loma Linda, California, United States
Jason Hoff, MD
Recruiting
University of California - San Francisco
San Francisco, California, United States
Sammy Elmariah, MD
Recruiting
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Joseph Aragon, MD
Recruiting
South Denver Cardiology Associates
Littleton, Colorado, United States
Lee MacDonald, MD
Recruiting
Medical Center of the Rockies
Loveland, Colorado, United States
Justin Strote, MD
Recruiting
Yale University School of Medicine
New Haven, Connecticut, United States
Jeremy Asnes, MD
Recruiting
Baptist Health Jacksonville
Jacksonville, Florida, United States
Recruiting
Naples Community Hospital
Naples, Florida, United States
Roberto Cubeddu, MD
Recruiting
University of Sf (tampa General Hospital)
Tampa, Florida, United States
Bibhu Mohanty, MD
Recruiting
Cleveland Clinic Florida
Weston, Florida, United States
Active, not recruiting
Emory University
Atlanta, Georgia, United States
Active, not recruiting
Rush University Medical Center
Chicago, Illinois, United States
Hussam Suradi, MD
Recruiting
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Withdrawn
Northwestern University
Evanston, Illinois, United States
Keith Benzuly, MD
Recruiting
University of Iowa Hospitals & Clinic
Iowa City, Iowa, United States
Phillip Horwitz, MD
Recruiting
Catholic Health Initiatives- Iowa Corp Dba Iowa Heart
West Des Moines, Iowa, United States
Mark Tannenbaum, MD
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Ignacio Inglessis-Azuaje, MD
Recruiting
University of Michigan
Ann Arbor, Michigan, United States
Stanley Chetcuti, MD
Recruiting
William Beaumont Hospital
Royal Oak, Michigan, United States
Withdrawn
Covenant Medical Center, Inc.
Saginaw, Michigan, United States
Terminated
University of Minnesota
Edina, Minnesota, United States
Withdrawn
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mario Goessl, MD
Recruiting
Jersey Shore University / Hackensack Umc
Freehold, New Jersey, United States
Withdrawn
Research Foundation Suny Buffalo
Buffalo, New York, United States
Vijay Iyer, MD
Recruiting
Columbia University Medical Center/nyph
New York, New York, United States
Terminated
Atrium Health
Charlotte, North Carolina, United States
Matthew Schwartz, MD
Recruiting
Providence Heart & Vascular Institute
Portland, Oregon, United States
Brandon Jones, MD
Recruiting
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Paul Hermany, MD
Recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Withdrawn
Tennova Healthcare
Knoxville, Tennessee, United States
Withdrawn
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Terminated
Baylor College of Medicine-Houston
Houston, Texas, United States
Dhaval Parekh, MD
Recruiting
the Methodist Hospital - Houston
Houston, Texas, United States
Chun Huie Lin, MD
Recruiting
Methodist Healthcare Systems of San Antonio D/b/a Methodist Hospital
San Antonio, Texas, United States
Active, not recruiting
Baylor Scott & White Memorial Hospital
Temple, Texas, United States
Robert Widmer, MD
Recruiting
St. Marks Hospital
Salt Lake City, Utah, United States
Vamsee Yaganti, MD
Recruiting
University of Utah
Salt Lake City, Utah, United States
Anwar Tandar, MD
Recruiting
University of Virginia
Charlottesville, Virginia, United States
John Thomas Saxon, MD
Recruiting

5 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 25 Jul 2019
Primary completion: 31 Oct 2028
Completion: 31 Oct 2031
Last update posted: 30 Jul 2026
Registered enrollment: 636
Registry id: NCT03821129

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.