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

Recruiting now · Not applicable

Conditions studied: Stroke, PFO - Patent Foramen Ovale

In brief

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 facts

Study ID

NCT03821129

Run by

W.L.Gore & Associates

People needed

636

Starts

2019-07-25

Expected to finish

2031-10-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
• Note: Additional Inclusion Criteria may apply

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
• Note: Additional Exclusion Criteria may apply

Where it is running

• Medical College of Wisconsin, Inc. — Milwaukee, Wisconsin, United States (enrolling)
• Scripps Health La Jolla — La Jolla, California, United States (enrolling)
• Loma Linda University Health — Loma Linda, California, United States (enrolling)
• University of California - San Francisco — San Francisco, California, United States (enrolling)
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States (enrolling)
• South Denver Cardiology Associates — Littleton, Colorado, United States (enrolling)
• Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• Baptist Health Jacksonville — Jacksonville, Florida, United States (enrolling)
• Naples Community Hospital — Naples, Florida, United States (enrolling)
• University of SF (Tampa General Hospital) — Tampa, Florida, United States (enrolling)
• Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital — Minneapolis, Minnesota, United States (enrolling)
• Research Foundation SUNY Buffalo — Buffalo, New York, United States (enrolling)
• Atrium Health — Charlotte, North Carolina, United States (enrolling)
• Providence Heart & Vascular Institute — Portland, Oregon, United States (enrolling)
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States (enrolling)
• Baylor College of Medicine-Houston — Houston, Texas, United States (enrolling)
• The Methodist Hospital - Houston — Houston, Texas, United States (enrolling)
• Baylor Scott & White Memorial Hospital — Temple, Texas, United States (enrolling)
• St. Marks Hospital — Salt Lake City, Utah, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• University of Virginia — Charlottesville, Virginia, United States (enrolling)
• Multicare Health Tacoma-Multicare Institute for Research & Innovation — Tacoma, Washington, United States (enrolling)
• Charleston Area Medical Center (CAMC) — Charleston, West Virginia, United States (enrolling)
• Aurora Health Care, Metro Inc. — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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