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
NCT ID: NCT03821129
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
636 participants
INTERVENTIONAL
2019-07-25
2031-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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GORE® CARDIOFORM Septal Occluder
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke
Interventions
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PFO closure with GORE® CARDIOFORM Septal Occluder
PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Locations
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St. Mary's Hospital
Tucson, Arizona, United States
Scripps Health La Jolla
La Jolla, California, United States
Loma Linda University Health
Loma Linda, California, United States
University of California - San Francisco
San Francisco, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Baptist Health Jacksonville
Jacksonville, Florida, United States
Naples Community Hospital
Naples, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Northwestern University
Evanston, Illinois, United States
University of Iowa Hospitals & Clinic
Iowa City, Iowa, United States
Catholic Health Initiatives- Iowa Corp dba Iowa Heart
West Des Moines, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Covenant Medical Center, Inc.
Saginaw, Michigan, United States
University of Minnesota
Edina, Minnesota, United States
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Jersey Shore University / Hackensack UMC
Freehold, New Jersey, United States
Research Foundation SUNY Buffalo
Buffalo, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Providence Heart & Vascular Institute
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Tennova Healthcare
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine-Houston
Houston, Texas, United States
The Methodist Hospital - Houston
Houston, Texas, United States
Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital
San Antonio, Texas, United States
Baylor Scott & White Memorial Hospital
Temple, Texas, United States
St. Marks Hospital
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Multicare Health Tacoma-Multicare Institute for Research & Innovation
Tacoma, Washington, United States
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, United States
Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Kaye Reambonanza
Role: primary
Siddharth Wayanganker, MD
Role: primary
Matthew Saybolt, MD
Role: primary
Richard Han, MD
Role: primary
Michael Cinquegrani
Role: primary
Other Identifiers
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GSO 18-01
Identifier Type: -
Identifier Source: org_study_id
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