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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

W.L.Gore & Associates · NCT03821129

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
636
US sites recruiting
31
Study start
July 25, 2019
Record last updated
July 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: PFO closure with GORE® CARDIOFORM Septal Occluder

Conditions: Stroke; PFO - Patent Foramen Ovale

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Scripps Health La Jolla

    La Jolla, CA 92037

    Site contact: Stefania Marzano · 858-824-5456 · marzano.stefania@scrippshealth.org

  • Loma Linda University Health

    Loma Linda, CA 92354

    Site contact: Shane Robbins · 909-651-9887 · srobbins@llu.edu

  • University of California - San Francisco

    San Francisco, CA 94143

    Site contact: Kaye Reambonanza · 415-514-6147

  • Santa Barbara Cottage Hospital

    Santa Barbara, CA 93105

    Site contact: Carmen Carbajal · 805-698-2432 · ccarbaja@sbch.org

  • South Denver Cardiology Associates

    Littleton, CO 80120

    Site contact: Rebecca Wimmer · 303-715-2275 · rwimmer@southdenver.com

  • Medical Center of the Rockies

    Loveland, CO 80538

    Site contact: Scott Kaczkowski · 970-624-1685 · scott.kaczkowski@uchealth.org

  • Yale University School of Medicine

    New Haven, CT 06510

    Site contact: Amanda Catucci · 203-785-6947 · amanda.catucci@yale.edu

  • Baptist Health Jacksonville

    Jacksonville, FL 32207

    Site contact: Siddharth Wayanganker, MD

  • Naples Community Hospital

    Naples, FL 34102

    Site contact: Linda Pastorius · 239-624-8393 · linda.pastorius@nchmd.org

  • University of SF (Tampa General Hospital)

    Tampa, FL 33606

    Site contact: Bibhu Mohanty, MD · 813-396-2617 · bmohanty@usf.edu

  • Rush University Medical Center

    Chicago, IL 60612

    Site contact: Abby Mason · 312-947-2997 · abby_mason@rush.edu

  • Northwestern University

    Evanston, IL 60208

    Site contact: Leonie Mbouguen · 312-926-0840 · leonieluciano.mbouguen@nm.org

  • University of Iowa Hospitals & Clinic

    Iowa City, IA 52242

    Site contact: Amy Ollinger · 319-353-6675 · amy-ollinger@uiowa.edu

  • Catholic Health Initiatives- Iowa Corp dba Iowa Heart

    West Des Moines, IA 50266

    Site contact: Kendra Tuttle · 515-235-5102 · kendra.tuttle@mercyoneiowa.org

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Sidney Searles · 617-643-9617 · ssearles@mgh.harvard.edu

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: Sweta Naik · 734-232-4277 · swetan@med.umich.edu

  • Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital

    Minneapolis, MN 55407

    Site contact: John Meriwether · 612-863-6288 · john.meriwether@allina.com

  • Research Foundation SUNY Buffalo

    Buffalo, NY 14203

    Site contact: Cassandra Davern · 716-982-6115 · cadavern@buffalo.edu

  • Atrium Health

    Charlotte, NC 28203

    Site contact: Krystal Winkler · 704-355-4794 · krystal.winkler@atriumhealth.org

  • Providence Heart & Vascular Institute

    Portland, OR 97225

    Site contact: Sarah Jackson · 503-216-7370 · sarah.jackson3@providence.org

  • Lehigh Valley Hospital

    Allentown, PA 18103

    Site contact: Francesca Sanchez · 610-402-1626 · francesca.sanchez@lvhn.org

  • Baylor College of Medicine-Houston

    Houston, TX 77030

    Site contact: Araceli Boan · 713-798-5670 · araceli.boan@bcm.edu

  • The Methodist Hospital - Houston

    Houston, TX 77030

    Site contact: Bora Yskollari · 713-441-3552 · byskollari@houstonmethodist.org

  • Baylor Scott & White Memorial Hospital

    Temple, TX 76508

    Site contact: Rohini Bagewadi · 254-724-1083 · rohini.bagewadi@bswhealth.org

  • St. Marks Hospital

    Salt Lake City, UT 84124

    Site contact: Megan Miller · 801-268-7883 · megan.miller@mountainstarhealth.com

  • University of Utah

    Salt Lake City, UT 84132

    Site contact: Jaymee Sanderson · 801-585-2975 · jaymee.sanderson@hsc.utah.edu

  • University of Virginia

    Charlottesville, VA 22908

    Site contact: Annika King · 434-982-1058 · ake5rq@uvahealth.org

  • Multicare Health Tacoma-Multicare Institute for Research & Innovation

    Tacoma, WA 98405

    Site contact: Tonya Stigger · 253-403-1208 · tonya.stigger@multicare.org

  • Charleston Area Medical Center (CAMC)

    Charleston, WV 25302

    Site contact: Richard Han, MD

  • Aurora Health Care, Metro Inc.

    Milwaukee, WI 53215

    Site contact: Donald Lobacz · 414-649-3438 · donald.lobacz@aah.org

  • Medical College of Wisconsin, Inc.

    Milwaukee, WI 53226

    Site contact: Michael Cinquegrani

Study contacts (from the official record)

  • Tammy DeLozier · 800-437-8181 · GSO1801@wlgore.com
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GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical… (NCT03821129) | Bored Studies