Actively Recruiting
GORE4 CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO) Post Approval Study
Led by W.L.Gore & Associates · Updated on 2026-05-05
636
Participants Needed
45
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the GORE4 CARDIOFORM Septal Occluder device in adults with patent foramen ovale (PFO) who have experienced an ischemic stroke. This post-approval study also looks at how well operator education and training transfer to real-world medical settings. The goal is to understand device performance and patient outcomes over time in a broader patient population. Participants will receive the GORE4 CARDIOFORM Septal Occluder device for PFO closure. This is a single-arm study using a commercially available device. After the implant procedure, participants will be followed up at 1 month, 6 months, 12 months, and then annually for up to 5 years to monitor device success and safety. The study focuses on detecting any recurrent strokes, device-related serious adverse events, and effectiveness of PFO closure. During the study, participants will undergo regular medical assessments including echocardiographic evaluations to assess PFO closure and check for any residual shunting. Researchers will also monitor for new atrial arrhythmias and record procedural success. Follow-up visits will include clinical evaluations and safety monitoring. The primary outcomes include the proportion of patients with recurrent ischemic stroke over 24 months and device- or procedure-related serious adverse events within 30 days post-implant. The total participation may last up to 5 years post-procedure to ensure long-term data collection.
CONDITIONS
Brief 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 within the last 365 days prior to enrollment, verified by a neurologist
- Presence of patent foramen ovale confirmed by positive bubble study using transesophageal echocardiography or transcranial Doppler
- Able to tolerate antiplatelet therapy
- Age between 18 and 70 years
- Note: Additional inclusion criteria may apply
You will not qualify if you...
- History of or ongoing atrial fibrillation or flutter
- Presence of mural thrombus, dilated cardiomyopathy, cardiac prosthetics, severe native valve disease, severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, or other serious heart conditions
- Prior intracranial hemorrhage or severe disability from previous stroke
- Autoimmune disorders increasing risk of stroke or infection
- Left ventricular ejection fraction below 40%
- Coexistent causes or intracardiac shunting other than PFO
- Previous myocardial infarction
- Rankin Scale score greater than or equal to 3 at procedure time
- Active infection not treatable before enrollment
- Neurological deficits unrelated to stroke
- Uncontrolled diabetes, hypertension, or pulmonary hypertension at screening or procedure
- Sensitivity or contraindication to study treatments or device components
- Pregnant, lactating, or intending pregnancy within 24 months after enrollment
- Cardiac anatomy or defect size unsuitable for device placement
- Need for multiple devices or additional procedures that may affect outcomes
- Note: Additional exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 1 year prior to enrollment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Single procedure day with hospital stay approximately 1 day
Participants receive the GORE® CARDIOFORM Septal Occluder device implant to close the patent foramen ovale.
1 procedure visit and hospitalization
Duration - Up to 5 years post implant
Participants have follow-up visits to monitor device effectiveness and safety, including assessment of recurrent stroke and device-related adverse events.
Visits at 1 month, 6 months, 12 months, and annually up to 5 years
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
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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