Recruiting

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

Sponsor:

W.L.Gore & Associates

Code:

NCT03821129

Conditions

Stroke

PFO - Patent Foramen Ovale

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

PFO closure with GORE® CARDIOFORM Septal Occluder

Study Details

Brief 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.

Conditions

Stroke

PFO - Patent Foramen Ovale

Study ID

NCT03821129

Start date

Jul 25, 2019

Status verified date

Jul, 2026

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.
Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
Patient is able to tolerate antiplatelet therapy
Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

History of or ongoing atrial fibrillation/flutter
Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular neurologic disorders, pulmonary arteriovenous malformations, prior intracranial hemorrhage, severe disability related to prior stroke, autoimmune disorders that would increase the risk of stroke or thromboembolism, or associated with increased risk of infection or procedural complications, in the opinion of the investigator, left ventricular ejection fraction of <40%, coexistent cause or intra-cardiac shunting (e.g. VSD or ASD)
Previous Myocardial Infarction
Rankin Scale sore greater than or equal to 3 at the time of procedure
Active infection that cannot be treated successfully prior to enrollment
Neurological deficits not due to stroke that may affect the patient's neurologic assessments
Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure
Sensitivity or contraindication to all proposed medical treatments or any device components
Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.
Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device.
Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder
Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
Note: Additional Exclusion Criteria may apply

Study Design

Enrollment

636 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: GORE® CARDIOFORM Septal Occluder

Single Arm Commercially available GORE® CARDIOFORM Septal Occluder

Interventions

PFO closure with GORE® CARDIOFORM Septal Occluder

PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke

Primary outcome measure

Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome) [ Time Frame: 24 months ]
Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Tammy DeLozier

800-437-8181 GSO1801@wlgore.com

Locations

Scripps Health La Jolla

Recruiting

La Jolla, California, United States, 92037

Contacts

Stefania Marzano

858-824-5456 marzano.stefania@scrippshealth.org

Principal Investigator:

Matthew Price, MD

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Contacts

Shane Robbins

909-651-9887 srobbins@llu.edu

Principal Investigator:

Jason Hoff, MD

University of California - San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Kaye Reambonanza

415-514-6147

Principal Investigator:

Sammy Elmariah, MD

Santa Barbara Cottage Hospital

Recruiting

Santa Barbara, California, United States, 93105

Contacts

Carmen Carbajal

805-698-2432 ccarbaja@sbch.org

Principal Investigator:

Joseph Aragon, MD

South Denver Cardiology Associates

Recruiting

Littleton, Colorado, United States, 80120

Contacts

Rebecca Wimmer

303-715-2275 rwimmer@southdenver.com

Principal Investigator:

Lee MacDonald, MD

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Scott Kaczkowski

970-624-1685 scott.kaczkowski@uchealth.org

Principal Investigator:

Justin Strote, MD

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Amanda Catucci

203-785-6947 amanda.catucci@yale.edu

Principal Investigator:

Jeremy Asnes, MD

Baptist Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Naples Community Hospital

Recruiting

Naples, Florida, United States, 34102

Contacts

Linda Pastorius

239-624-8393 linda.pastorius@nchmd.org

Principal Investigator:

Roberto Cubeddu, MD

University of SF (Tampa General Hospital)

Recruiting

Tampa, Florida, United States, 33606

Contacts

Bibhu Mohanty, MD

813-396-2617 bmohanty@usf.edu

Principal Investigator:

Bibhu Mohanty, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Abby Mason

312-947-2997 abby_mason@rush.edu

Principal Investigator:

Hussam Suradi, MD

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Leonie Mbouguen

312-926-0840 leonieluciano.mbouguen@nm.org

Principal Investigator:

Keith Benzuly, MD

University of Iowa Hospitals & Clinic

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Amy Ollinger

319-353-6675 amy-ollinger@uiowa.edu

Principal Investigator:

Phillip Horwitz, MD

Catholic Health Initiatives- Iowa Corp dba Iowa Heart

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Kendra Tuttle

515-235-5102 kendra.tuttle@mercyoneiowa.org

Principal Investigator:

Mark Tannenbaum, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sidney Searles

617-643-9617 ssearles@mgh.harvard.edu

Principal Investigator:

Ignacio Inglessis-Azuaje, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Sweta Naik

734-232-4277 swetan@med.umich.edu

Principal Investigator:

Stanley Chetcuti, MD

Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

John Meriwether

612-863-6288 john.meriwether@allina.com

Principal Investigator:

Mario Goessl, MD

Research Foundation SUNY Buffalo

Recruiting

Buffalo, New York, United States, 14203

Contacts

Cassandra Davern

716-982-6115 cadavern@buffalo.edu

Principal Investigator:

Vijay Iyer, MD

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Krystal Winkler

704-355-4794 krystal.winkler@atriumhealth.org

Principal Investigator:

Matthew Schwartz, MD

Providence Heart & Vascular Institute

Recruiting

Portland, Oregon, United States, 97225

Contacts

Sarah Jackson

503-216-7370 sarah.jackson3@providence.org

Principal Investigator:

Brandon Jones, MD

Lehigh Valley Hospital

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Francesca Sanchez

610-402-1626 francesca.sanchez@lvhn.org

Principal Investigator:

Paul Hermany, MD

Baylor College of Medicine-Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Araceli Boan

713-798-5670 araceli.boan@bcm.edu

Principal Investigator:

Dhaval Parekh, MD

The Methodist Hospital - Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Bora Yskollari

713-441-3552 byskollari@houstonmethodist.org

Principal Investigator:

Chun Huie Lin, MD

Baylor Scott & White Memorial Hospital

Recruiting

Temple, Texas, United States, 76508

Contacts

Rohini Bagewadi

254-724-1083 rohini.bagewadi@bswhealth.org

Principal Investigator:

Robert Widmer, MD

St. Marks Hospital

Recruiting

Salt Lake City, Utah, United States, 84124

Contacts

Megan Miller

801-268-7883 megan.miller@mountainstarhealth.com

Principal Investigator:

Vamsee Yaganti, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Jaymee Sanderson

801-585-2975 jaymee.sanderson@hsc.utah.edu

Principal Investigator:

Anwar Tandar, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Annika King

434-982-1058 ake5rq@uvahealth.org

Principal Investigator:

John Thomas Saxon, MD

Multicare Health Tacoma-Multicare Institute for Research & Innovation

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Tonya Stigger

253-403-1208 tonya.stigger@multicare.org

Principal Investigator:

Kurt Kinney, MD

Charleston Area Medical Center (CAMC)

Recruiting

Charleston, West Virginia, United States, 25302

Aurora Health Care, Metro Inc.

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Donald Lobacz

414-649-3438 donald.lobacz@aah.org

Principal Investigator:

Tanvir Bajwa, MD

Medical College of Wisconsin, Inc.

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

W.L.Gore & Associates

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

Occluder
Patent Foramen Ovale
PFO
Stroke
Gore Septal Occluder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by W.L.Gore & Associates on 2026-07-30.