Actively Recruiting
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
Led by W.L.Gore & Associates · Updated on 2026-05-05
636
Participants Needed
45
Research Sites
635 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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), confirmed by positive bubble study using transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), showing right-to-left shunting spontaneously or with Valsalva maneuver.
- Patient is able to tolerate antiplatelet therapy.
- Note: Additional Inclusion Criteria may apply
You will not qualify if you...
- History of or ongoing atrial fibrillation or flutter.
- Other significant heart conditions such as mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease including mitral valve stenosis, severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, or vasculitis.
- Pre-existing non-vascular neurologic disorders.
- Pulmonary arteriovenous malformations.
- Prior intracranial hemorrhage.
- Severe disability related to prior stroke.
- Autoimmune disorders increasing risk of stroke, thromboembolism, infection, or procedural complications.
- Left ventricular ejection fraction less than 40%.
- Coexistent cause or intracardiac shunting such as ventricular septal defect (VSD) or atrial septal defect (ASD).
- Previous myocardial infarction.
- Rankin Scale score of 3 or greater at the time of procedure.
- Active infection that cannot be successfully treated before enrollment.
- Neurological deficits not caused by stroke that may affect neurologic assessments.
- Evidence of hypercoagulable state, uncontrolled diabetes, uncontrolled systemic or pulmonary hypertension at screening or procedure.
- Sensitivity or contraindication to proposed medical treatments or device components.
- Pregnant, breastfeeding, or planning pregnancy through 24 months after enrollment.
- Conditions outside device placement parameters including extensive congenital cardiac anomalies or defect sizes too large for closure with the device.
- Atrial septal anatomy requiring placement of more than one device.
- Need for other procedures that might interfere with detecting device-related adverse events.
- Note: Additional Exclusion Criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
St. Mary's Hospital
Tucson, Arizona, United States, 85745
Withdrawn
2
Scripps Health La Jolla
La Jolla, California, United States, 92037
Actively Recruiting
3
Loma Linda University Health
Loma Linda, California, United States, 92354
Actively Recruiting
4
University of California - San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
5
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Actively Recruiting
6
South Denver Cardiology Associates
Littleton, Colorado, United States, 80120
Actively Recruiting
7
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Actively Recruiting
8
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
Baptist Health Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
10
Naples Community Hospital
Naples, Florida, United States, 34102
Actively Recruiting
11
University of SF (Tampa General Hospital)
Tampa, Florida, United States, 33606
Actively Recruiting
12
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Active, Not Recruiting
13
Emory University
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
14
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
15
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Withdrawn
16
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
17
University of Iowa Hospitals & Clinic
Iowa City, Iowa, United States, 52242
Actively Recruiting
18
Catholic Health Initiatives- Iowa Corp dba Iowa Heart
West Des Moines, Iowa, United States, 50266
Actively Recruiting
19
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
20
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
21
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Withdrawn
22
Covenant Medical Center, Inc.
Saginaw, Michigan, United States, 48602
Terminated
23
University of Minnesota
Edina, Minnesota, United States, 55435
Withdrawn
24
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
25
Jersey Shore University / Hackensack UMC
Freehold, New Jersey, United States, 07728
Actively Recruiting
26
Research Foundation SUNY Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
27
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Terminated
28
Atrium Health
Charlotte, North Carolina, United States, 28203
Actively Recruiting
29
Providence Heart & Vascular Institute
Portland, Oregon, United States, 97225
Actively Recruiting
30
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
31
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Withdrawn
32
Tennova Healthcare
Knoxville, Tennessee, United States, 37934
Withdrawn
33
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Terminated
34
Baylor College of Medicine-Houston
Houston, Texas, United States, 77030
Actively Recruiting
35
The Methodist Hospital - Houston
Houston, Texas, United States, 77030
Actively Recruiting
36
Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital
San Antonio, Texas, United States, 78229
Active, Not Recruiting
37
Baylor Scott & White Memorial Hospital
Temple, Texas, United States, 76508
Actively Recruiting
38
St. Marks Hospital
Salt Lake City, Utah, United States, 84124
Actively Recruiting
39
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
40
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
41
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23455
Terminated
42
Multicare Health Tacoma-Multicare Institute for Research & Innovation
Tacoma, Washington, United States, 98405
Actively Recruiting
43
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, United States, 25302
Actively Recruiting
44
Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
45
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
T
Tammy DeLozier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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