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 (REDUCE PAS)

April 28, 2026 updated by: W.L.Gore & Associates
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

636

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85745
        • Withdrawn
        • St. Mary's Hospital
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Health La Jolla
        • Principal Investigator:
          • Matthew Price, MD
        • Contact:
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Health
        • Principal Investigator:
          • Jason Hoff, MD
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California - San Francisco
        • Principal Investigator:
          • Sammy Elmariah, MD
        • Contact:
          • Kaye Reambonanza
          • Phone Number: 415-514-6147
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Santa Barbara Cottage Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Aragon, MD
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • South Denver Cardiology Associates
        • Principal Investigator:
          • Lee MacDonald, MD
        • Contact:
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Contact:
        • Principal Investigator:
          • Justin Strote, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School of Medicine
        • Principal Investigator:
          • Jeremy Asnes, MD
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Jacksonville
        • Contact:
          • Siddharth Wayanganker, MD
      • Naples, Florida, United States, 34102
        • Recruiting
        • Naples Community Hospital
        • Principal Investigator:
          • Roberto Cubeddu, MD
        • Contact:
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of SF (Tampa General Hospital)
        • Principal Investigator:
          • Bibhu Mohanty, MD
        • Contact:
      • Weston, Florida, United States, 33331
        • Active, not recruiting
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Active, not recruiting
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Hussam Suradi, MD
        • Contact:
      • Elk Grove Village, Illinois, United States, 60007
        • Withdrawn
        • Alexian Brothers Medical Center
      • Evanston, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Keith Benzuly, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals & Clinic
        • Principal Investigator:
          • Phillip Horwitz, MD
        • Contact:
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Catholic Health Initiatives- Iowa Corp dba Iowa Heart
        • Principal Investigator:
          • Mark Tannenbaum, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Ignacio Inglessis-Azuaje, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Stanley Chetcuti, MD
        • Contact:
      • Royal Oak, Michigan, United States, 48073
        • Withdrawn
        • William Beaumont Hospital
      • Saginaw, Michigan, United States, 48602
        • Terminated
        • Covenant Medical Center, Inc.
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Withdrawn
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
        • Principal Investigator:
          • Mario Goessl, MD
        • Contact:
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Recruiting
        • Jersey Shore University / Hackensack UMC
        • Principal Investigator:
          • Matthew Saybolt, MD
        • Contact:
          • Matthew Saybolt, MD
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Research Foundation SUNY Buffalo
        • Principal Investigator:
          • Vijay Iyer, MD
        • Contact:
      • New York, New York, United States, 10032
        • Terminated
        • Columbia University Medical Center/NYPH
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Atrium Health
        • Principal Investigator:
          • Matthew Schwartz, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Heart & Vascular Institute
        • Principal Investigator:
          • Brandon Jones, MD
        • Contact:
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital
        • Contact:
        • Principal Investigator:
          • Paul Hermany, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Withdrawn
        • Medical University of South Carolina
    • Tennessee
      • Knoxville, Tennessee, United States, 37934
        • Withdrawn
        • Tennova Healthcare
      • Nashville, Tennessee, United States, 37232
        • Terminated
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital - Houston
        • Contact:
        • Principal Investigator:
          • Chun Huie Lin, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine-Houston
        • Contact:
        • Principal Investigator:
          • Dhaval Parekh, MD
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital
      • Temple, Texas, United States, 76508
        • Recruiting
        • Baylor Scott & White Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Robert Widmer, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • Anwar Tandar, MD
      • Salt Lake City, Utah, United States, 84124
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Contact:
        • Principal Investigator:
          • John Thomas Saxon, MD
      • Norfolk, Virginia, United States, 23455
        • Terminated
        • Sentara Cardiovascular Research Institute
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Multicare Health Tacoma-Multicare Institute for Research & Innovation
        • Contact:
        • Principal Investigator:
          • Kurt Kinney, MD
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • Recruiting
        • Charleston Area Medical Center (CAMC)
        • Contact:
          • Richard Han, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Health Care, Metro Inc.
        • Contact:
        • Principal Investigator:
          • Tanvir Bajwa, MD
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin, Inc.
        • Contact:
          • Michael Cinquegrani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: GORE® CARDIOFORM Septal Occluder
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
Device: PFO closure with GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment
Time Frame: 12 months

Complete PFO closure or a trivial or small residual shunt

Proportion of subjects with complete PFO closure or a trivial or small residual shunt
12 months
Clinically Significant New Atrial Arrhythmia
Time Frame: 60 months
Any new atrial fibrillation or flutter
60 months
Clinically Significant New Atrial Arrhythmia by Age
Time Frame: 60 months
Any new atrial fibrillation or flutter in patients greater and less than 60 years of age
60 months
Residual Shunt Characterization via assessment of shunt in patients by Echo
Time Frame: 24 months
Assessment of shunt in patients by Echo
24 months
Technical Success defined as successful delivery and retention of the GSO device based on physician reporting
Time Frame: Index procedure
Successful delivery and retention of the GSO device
Index procedure
Procedural Success defined as successful implantation of the GSO device with no reported in-hospital Serious Adverse Events (SAEs)
Time Frame: Enrollment through discharge, approximately 1 day
Successful implantation of the GSO device with no reported in-hospital SAEs
Enrollment through discharge, approximately 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Investigators

  • Principal Investigator: Ignacio Inglessis, MD, Interventional Cardiology Associates
  • Principal Investigator: John Volpi, MD, The Methodist Hospital Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2019

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSO 18-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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