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RECRUITING

NCT03821129

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

Sponsor: W.L.Gore & Associates

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

636

Start Date

2019-07-25

Completion Date

2031-10

Last Updated

2025-09-11

Healthy Volunteers

Conditions

Stroke PFO - Patent Foramen Ovale

Interventions

DEVICE

PFO closure with GORE® CARDIOFORM Septal Occluder

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

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

Locations (44)

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.