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StrokeREDUCE PASNCT03821129

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

A study testing PFO closure with GORE® CARDIOFORM Septal Occluder in people with Stroke and PFO - Patent Foramen Ovale, run by W.L.Gore & Associates at 45 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Stroke, PFO - Patent Foramen Ovale
What is being tested?
PFO closure with GORE® CARDIOFORM Septal Occluder
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
636 participants
Where
45 sitesUnited States
Study dates
25 Jul 2019to Oct 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

45 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tammy DeLozier contact

800-437-8181

GSO1801@wlgore.com

45 sites in 1 country

United States45 sites, 31 recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

    Francesca Sanchez, 610-402-1626, francesca.sanchez@lvhn.org

    Paul Hermany, MD

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Sweta Naik, 734-232-4277, swetan@med.umich.edu

    Stanley Chetcuti, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Active, not recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Sidney Searles, 617-643-9617, ssearles@mgh.harvard.edu

    Ignacio Inglessis-Azuaje, MD

    Recruiting

  • Research Foundation SUNY Buffalo

    Buffalo, New York, 14203

    Cassandra Davern, 716-982-6115, cadavern@buffalo.edu

    Vijay Iyer, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Withdrawn

  • Charleston Area Medical Center (CAMC)

    Charleston, West Virginia, 25302

    Richard Han, MD

    Recruiting

  • Atrium Health

    Charlotte, North Carolina, 28203

    Krystal Winkler, 704-355-4794, krystal.winkler@atriumhealth.org

    Matthew Schwartz, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Annika King, 434-982-1058, ake5rq@uvahealth.org

    John Thomas Saxon, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Abby Mason, 312-947-2997, abby_mason@rush.edu

    Hussam Suradi, MD

    Recruiting

  • University of Minnesota

    Edina, Minnesota, 55435

    Withdrawn

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

    Withdrawn

  • Northwestern University

    Evanston, Illinois, 60208

    Leonie Mbouguen, 312-926-0840, leonieluciano.mbouguen@nm.org

    Keith Benzuly, MD

    Recruiting

  • Jersey Shore University / Hackensack UMC

    Freehold, New Jersey, 07728

    Withdrawn

  • Baylor College of Medicine-Houston

    Houston, Texas, 77030

    Araceli Boan, 713-798-5670, araceli.boan@bcm.edu

    Dhaval Parekh, MD

    Recruiting

  • The Methodist Hospital - Houston

    Houston, Texas, 77030

    Bora Yskollari, 713-441-3552, byskollari@houstonmethodist.org

    Chun Huie Lin, MD

    Recruiting

  • University of Iowa Hospitals & Clinic

    Iowa City, Iowa, 52242

    Amy Ollinger, 319-353-6675, amy-ollinger@uiowa.edu

    Phillip Horwitz, MD

    Recruiting

  • Baptist Health Jacksonville

    Jacksonville, Florida, 32207

    Siddharth Wayanganker, MD

    Recruiting

  • Tennova Healthcare

    Knoxville, Tennessee, 37934

    Withdrawn

  • Scripps Health La Jolla

    La Jolla, California, 92037

    Stefania Marzano, 858-824-5456, marzano.stefania@scrippshealth.org

    Matthew Price, MD

    Recruiting

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120

    Rebecca Wimmer, 303-715-2275, rwimmer@southdenver.com

    Lee MacDonald, MD

    Recruiting

  • Loma Linda University Health

    Loma Linda, California, 92354

    Shane Robbins, 909-651-9887, srobbins@llu.edu

    Jason Hoff, MD

    Recruiting

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

    Scott Kaczkowski, 970-624-1685, scott.kaczkowski@uchealth.org

    Justin Strote, MD

    Recruiting

  • Aurora Health Care, Metro Inc.

    Milwaukee, Wisconsin, 53215

    Donald Lobacz, 414-649-3438, donald.lobacz@aah.org

    Tanvir Bajwa, MD

    Recruiting

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

    Michael Cinquegrani

    Recruiting

  • Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

    John Meriwether, 612-863-6288, john.meriwether@allina.com

    Mario Goessl, MD

    Recruiting

  • Naples Community Hospital

    Naples, Florida, 34102

    Linda Pastorius, 239-624-8393, linda.pastorius@nchmd.org

    Roberto Cubeddu, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Terminated

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

    Amanda Catucci, 203-785-6947, amanda.catucci@yale.edu

    Jeremy Asnes, MD

    Recruiting

  • Columbia University Medical Center/NYPH

    New York, New York, 10032

    Terminated

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23455

    Terminated

  • Providence Heart & Vascular Institute

    Portland, Oregon, 97225

    Sarah Jackson, 503-216-7370, sarah.jackson3@providence.org

    Brandon Jones, MD

    Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

    Withdrawn

  • Covenant Medical Center, Inc.

    Saginaw, Michigan, 48602

    Terminated

  • St. Marks Hospital

    Salt Lake City, Utah, 84124

    Megan Miller, 801-268-7883, megan.miller@mountainstarhealth.com

    Vamsee Yaganti, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Jaymee Sanderson, 801-585-2975, jaymee.sanderson@hsc.utah.edu

    Anwar Tandar, MD

    Recruiting

  • Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital

    San Antonio, Texas, 78229

    Active, not recruiting

  • University of California - San Francisco

    San Francisco, California, 94143

    Kaye Reambonanza, 415-514-6147

    Sammy Elmariah, MD

    Recruiting

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

    Carmen Carbajal, 805-698-2432, ccarbaja@sbch.org

    Joseph Aragon, MD

    Recruiting

  • Multicare Health Tacoma-Multicare Institute for Research & Innovation

    Tacoma, Washington, 98405

    Tonya Stigger, 253-403-1208, tonya.stigger@multicare.org

    Kurt Kinney, MD

    Recruiting

  • University of SF (Tampa General Hospital)

    Tampa, Florida, 33606

    Bibhu Mohanty, MD, 813-396-2617, bmohanty@usf.edu

    Bibhu Mohanty, MD

    Recruiting

  • Baylor Scott & White Memorial Hospital

    Temple, Texas, 76508

    Rohini Bagewadi, 254-724-1083, rohini.bagewadi@bswhealth.org

    Robert Widmer, MD

    Recruiting

  • St. Mary's Hospital

    Tucson, Arizona, 85745

    Withdrawn

  • Catholic Health Initiatives- Iowa Corp dba Iowa Heart

    West Des Moines, Iowa, 50266

    Kendra Tuttle, 515-235-5102, kendra.tuttle@mercyoneiowa.org

    Mark Tannenbaum, MD

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331

    Active, not recruiting

Other trials in United States

About this study

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.

Read the detailed description

A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.

Being tested
PFO closure with GORE® CARDIOFORM Septal Occluder
Keywords
Occluder, Patent Foramen Ovale, PFO, Stroke, Gore Septal Occluder
Medical subject headings
Stroke, Foramen Ovale, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PFO closure with GORE® CARDIOFORM Septal OccluderDevice

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

Study groups in NCT03821129
Study groupRoleWhat they receive
GORE® CARDIOFORM Septal OccluderOtherSingle Arm Commercially available GORE® CARDIOFORM Septal Occluder
Receives: Device: PFO closure with GORE® CARDIOFORM Septal Occluder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome)

    Proportion of subjects with recurrent ischemic stroke post study device implant

    Measured: 24 months

  2. Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)

    Device- or procedure- related serious adverse events post study device implant

    Measured: 30 days

Secondary outcomes (6)

  1. Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment

    Complete PFO closure or a trivial or small residual shunt

    Proportion of subjects with complete PFO closure or a trivial or small residual shunt

    Measured: 12 months

  2. Clinically Significant New Atrial Arrhythmia

    Any new atrial fibrillation or flutter

    Measured: 60 months

  3. Clinically Significant New Atrial Arrhythmia by Age

    Any new atrial fibrillation or flutter in patients greater and less than 60 years of age

    Measured: 60 months

  4. Residual Shunt Characterization via assessment of shunt in patients by Echo

    Assessment of shunt in patients by Echo

    Measured: 24 months

  5. Technical Success defined as successful delivery and retention of the GSO device based on physician reporting

    Successful delivery and retention of the GSO device

    Measured: Index procedure

  6. Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs)

    Successful implantation of the GSO device with no reported in-hospital SAEs

    Measured: Enrollment through discharge, approximately 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2019
  2. Study start25 Jul 2019
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
636 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03821129
Sponsor's protocol ID
GSO 18-01
Acronym
REDUCE PAS
Status last verified
Jul 2026
First submitted
15 Jan 2019
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PFO closure with GORE® CARDIOFORM Septal Occluder in people with Stroke and PFO - Patent Foramen Ovale, run by W.L.Gore & Associates at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tammy DeLozier (800-437-8181, GSO1801@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03821129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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