Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion (NCT05069558)
Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
🩺 Plain-English Summary (8th-Grade Level)
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).
Who can join: Review the eligibility criteria below.
Location: Arizona Cardiovascular Research Center — Phoenix, Arizona
Age range: 18 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 (48 Sites)
Showing the first 25 of 48 sites.
- Arizona Cardiovascular Research Center — Phoenix, Arizona
- Stanford University Medical Center — Stanford, California
- Los Robles Medical Center — Thousand Oaks, California
- Colorado Heart and Vascular PC / St. Anthony Hospital — Lakewood, Colorado
- South Denver Cardiology Associates — Littleton, Colorado
- Medstar Washington Hospital Center — Washington D.C., District of Columbia
- Rush University Medical Center — Chicago, Illinois
- OSF Saint Francis Medical Center — Peoria, Illinois
- University of Louisville — Louisville, Kentucky
- MaineHealth — Portland, Maine
- Tufts New England Medical Center — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Baystate Medical Center — Springfield, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Essentia Health — Duluth, Minnesota
- University of Nebraska Medical Center — Omaha, Nebraska
- The Valley Hospital — Paramus, New Jersey
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- The Ohio State University — Columbus, Ohio
- Ohio Health Research Institute — Columbus, Ohio
- Oklahoma Heart Hospital — Oklahoma City, Oklahoma
- Oregon Health & Science University — Portland, Oregon
- UPMC Presbyterian — Pittsburgh, Pennsylvania
- Vanderbilt Medical Center — Nashville, Tennessee
💰 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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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.