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

NCT03821129 | Recruiting DMC FDA Device

• 1 other identifier: GSO 18-01
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 45

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

Keywords

Occluder; Patent Foramen Ovale; PFO; Stroke; Gore Septal Occluder

Outcome Measures

Primary Outcomes (2)

• 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

  24 months

• 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

  30 days

Secondary Outcomes (6)

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

  12 months

• Clinically Significant New Atrial Arrhythmia

  60 months

• Clinically Significant New Atrial Arrhythmia by Age

  60 months

• Residual Shunt Characterization via 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

  Index procedure

Study Arms (1)

GORE® CARDIOFORM Septal Occluder

OTHER

Single Arm Commercially available GORE® CARDIOFORM Septal Occluder

Device: PFO closure with GORE® CARDIOFORM Septal Occluder

Interventions

PFO closure with GORE® CARDIOFORM Septal Occluder DEVICE

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

GORE® CARDIOFORM Septal Occluder

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (45)

St. Mary's Hospital

Tucson, Arizona, 85745, United States

WITHDRAWN

Scripps Health La Jolla

La Jolla, California, 92037, United States

RECRUITING

Loma Linda University Health

Loma Linda, California, 92354, United States

RECRUITING

University of California - San Francisco

San Francisco, California, 94143, United States

RECRUITING

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

RECRUITING

South Denver Cardiology Associates

Littleton, Colorado, 80120, United States

RECRUITING

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

RECRUITING

Baptist Health Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

Naples Community Hospital

Naples, Florida, 34102, United States

RECRUITING

University of SF (Tampa General Hospital)

Tampa, Florida, 33606, United States

RECRUITING

Cleveland Clinic Florida

Weston, Florida, 33331, United States

ACTIVE NOT RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

ACTIVE NOT RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

WITHDRAWN

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

University of Iowa Hospitals & Clinic

Iowa City, Iowa, 52242, United States

RECRUITING

Catholic Health Initiatives- Iowa Corp dba Iowa Heart

West Des Moines, Iowa, 50266, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

WITHDRAWN

Covenant Medical Center, Inc.

Saginaw, Michigan, 48602, United States

TERMINATED

University of Minnesota

Edina, Minnesota, 55435, United States

WITHDRAWN

Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

RECRUITING

Jersey Shore University / Hackensack UMC

Freehold, New Jersey, 07728, United States

RECRUITING

Research Foundation SUNY Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

TERMINATED

Atrium Health

Charlotte, North Carolina, 28203, United States

RECRUITING

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

RECRUITING

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

WITHDRAWN

Tennova Healthcare

Knoxville, Tennessee, 37934, United States

WITHDRAWN

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

TERMINATED

Baylor College of Medicine-Houston

Houston, Texas, 77030, United States

RECRUITING

The Methodist Hospital - Houston

Houston, Texas, 77030, United States

RECRUITING

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

San Antonio, Texas, 78229, United States

ACTIVE NOT RECRUITING

Baylor Scott & White Memorial Hospital

Temple, Texas, 76508, United States

RECRUITING

St. Marks Hospital

Salt Lake City, Utah, 84124, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23455, United States

TERMINATED

Multicare Health Tacoma-Multicare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

RECRUITING

Charleston Area Medical Center (CAMC)

Charleston, West Virginia, 25302, United States

RECRUITING

Aurora Health Care, Metro Inc.

Milwaukee, Wisconsin, 53215, United States

RECRUITING

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Tammy DeLozier

CONTACT

800-437-8181; GSO1801@wlgore.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 29, 2019
• Study Start: July 25, 2019
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (45)