🏛️ Verified NIH Record • Updated 2026-07-28
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 (NCT03821129)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: W.L.Gore & Associates
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: St. Mary's Hospital — Tucson, Arizona
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (45 Sites)
Showing the first 25 of 45 sites.
- St. Mary's Hospital — Tucson, Arizona
- Scripps Health La Jolla — La Jolla, California
- Loma Linda University Health — Loma Linda, California
- University of California - San Francisco — San Francisco, California
- Santa Barbara Cottage Hospital — Santa Barbara, California
- South Denver Cardiology Associates — Littleton, Colorado
- Medical Center of the Rockies — Loveland, Colorado
- Yale University School of Medicine — New Haven, Connecticut
- Baptist Health Jacksonville — Jacksonville, Florida
- Naples Community Hospital — Naples, Florida
- University of SF (Tampa General Hospital) — Tampa, Florida
- Cleveland Clinic Florida — Weston, Florida
- Emory University — Atlanta, Georgia
- Rush University Medical Center — Chicago, Illinois
- Alexian Brothers Medical Center — Elk Grove Village, Illinois
- Northwestern University — Evanston, Illinois
- University of Iowa Hospitals & Clinic — Iowa City, Iowa
- Catholic Health Initiatives- Iowa Corp dba Iowa Heart — West Des Moines, Iowa
- Massachusetts General Hospital — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- William Beaumont Hospital — Royal Oak, Michigan
- Covenant Medical Center, Inc. — Saginaw, Michigan
- University of Minnesota — Edina, Minnesota
- Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital — Minneapolis, Minnesota
- Jersey Shore University / Hackensack UMC — Freehold, New Jersey
📞 Contact the Study Coordinator
Phone: (800) 437-8181
Email: GSO1801@wlgore.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Determining the Optimal Dose of Reactive Balance Training After Stroke — Toronto, Ontario
- AMPLATZER PFO Occluder Post Approval Study — Birmingham, Alabama
- Reflex Excitability in Post-stroke Stiff-Knee Gait — Cleveland, Ohio
- Group Lifestyle Balance™ for Individuals With Stroke (GLB-CVA) — Dallas, Texas
Explore by condition: All Stroke clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.