RecruitingNot ApplicableNCT03821129

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

Enrollment

636 participants

Start Date

Jul 25, 2019

Study Type

INTERVENTIONAL

Conditions

Stroke PFO - Patent Foramen Ovale

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This post-approval study is evaluating the GORE CARDIOFORM Septal Occluder — a small closure device — for reducing the risk of a second stroke in patients who have a Patent Foramen Ovale (PFO), a small hole between the heart's upper chambers that failed to close at birth. PFO closure has been shown to reduce stroke recurrence, and this study tracks real-world long-term outcomes after the procedure. You may be eligible if: - You are between 18 and 70 years old - You have had a stroke within the past year that is believed to be caused by an embolism of undetermined source (ESUS) - You have a confirmed PFO with evidence of right-to-left shunting on bubble study (via TEE or TCD) - You can tolerate antiplatelet therapy You may NOT be eligible if: - You have a history of atrial fibrillation or flutter - You have another heart condition (dilated cardiomyopathy, severe valve disease, prosthetic valves, etc.) - You have had a previous heart attack - You have a Rankin disability score of 3 or higher from a prior stroke - You are pregnant, breastfeeding, or planning to become pregnant within 24 months - You have uncontrolled diabetes, hypertension, or pulmonary hypertension - You have a hypercoagulable condition, prior intracranial hemorrhage, or vasculitis Talk to your neurologist and cardiologist about your stroke workup, cardiac imaging findings, and current medications before considering this study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPFO closure with GORE® CARDIOFORM Septal Occluder

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

Locations(45)

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

University of SF (Tampa General Hospital)

Tampa, 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

View Full Details on ClinicalTrials.gov

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NCT03821129

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