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
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
St. Mary's Hospital
WITHDRAWN
Tucson
California
Scripps Health La Jolla
RECRUITING
La Jolla
Loma Linda University Health
RECRUITING
Loma Linda
University of California - San Francisco
RECRUITING
San Francisco
Santa Barbara Cottage Hospital
RECRUITING
Santa Barbara
Colorado
South Denver Cardiology Associates
RECRUITING
Littleton
Medical Center of the Rockies
RECRUITING
Loveland
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Florida
Baptist Health Jacksonville
RECRUITING
Jacksonville
Naples Community Hospital
RECRUITING
Naples
Cleveland Clinic Florida
ACTIVE_NOT_RECRUITING
Weston
Georgia
Emory University
ACTIVE_NOT_RECRUITING
Atlanta
Iowa
University of Iowa Hospitals & Clinic
RECRUITING
Iowa City
Catholic Health Initiatives- Iowa Corp dba Iowa Heart
RECRUITING
West Des Moines
Illinois
Rush University Medical Center
RECRUITING
Chicago
Alexian Brothers Medical Center
WITHDRAWN
Elk Grove Village
Northwestern University
RECRUITING
Evanston
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
William Beaumont Hospital
WITHDRAWN
Royal Oak
Covenant Medical Center, Inc.
TERMINATED
Saginaw
Minnesota
University of Minnesota
WITHDRAWN
Edina
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
RECRUITING
Minneapolis
North Carolina
Atrium Health
RECRUITING
Charlotte
New Jersey
Jersey Shore University / Hackensack UMC
RECRUITING
Freehold
New York
Research Foundation SUNY Buffalo
RECRUITING
Buffalo
Columbia University Medical Center/NYPH
TERMINATED
New York
Oregon
Providence Heart & Vascular Institute
RECRUITING
Portland
Pennsylvania
Lehigh Valley Hospital
RECRUITING
Allentown
South Carolina
Medical University of South Carolina
WITHDRAWN
Charleston
Tennessee
Tennova Healthcare
WITHDRAWN
Knoxville
Vanderbilt University Medical Center
ACTIVE_NOT_RECRUITING
Nashville
Texas
Baylor College of Medicine-Houston
RECRUITING
Houston
The Methodist Hospital - Houston
RECRUITING
Houston
Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital
ACTIVE_NOT_RECRUITING
San Antonio
Baylor Scott & White Memorial Hospital
RECRUITING
Temple
Utah
St. Marks Hospital
RECRUITING
Salt Lake City
University of Utah
RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Sentara Cardiovascular Research Institute
TERMINATED
Norfolk
Washington
Multicare Health Tacoma-Multicare Institute for Research & Innovation
RECRUITING
Tacoma
Wisconsin
Aurora Health Care, Metro Inc.
RECRUITING
Milwaukee
Medical College of Wisconsin, Inc.
RECRUITING
Milwaukee
West Virginia
Charleston Area Medical Center (CAMC)
RECRUITING
Charleston
Contact Information
Primary
Tammy DeLozier
GSO1801@wlgore.com
800-437-8181
Time Frame
Start Date: 2019-07-25
Estimated Completion Date: 2031-10
Participants
Target number of participants: 636
Treatments
Other: GORE® CARDIOFORM Septal Occluder
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
Authors
Related Therapeutic Areas
Sponsors
Leads: W.L.Gore & Associates