Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Active, not recruiting · Not applicable · NCT05069558
Conditions: Stroke, Patent Foramen Ovale, PFO
At a glance
- Research payments reported, 2025
- $262,063
- U.S. investigators named
- 0
- Sites paid
- 13
- Planned or actual enrollment
- 450
About the trial
- Sponsor
- Occlutech International AB
- Tested
- Investigational PFO Closure Device (device), Standard of Care PFO Closure Device (device)
- Dates
- Started 2022-05-09; completion 2029-11
- Results posted
- Not yet
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).
From ClinicalTrials.gov, last updated 2026-10-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Occlutech US LLC reported $262,063 in research payments for this study in 2025 (13 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
Sites paid to run it
- Baystate Medical Center, MA $81,553
- Tufts Medical Center, MA $41,770
- Ohsu Hospital and Clinics, OR $27,301
- Rush University Medical Center, IL $22,301
- Massachusetts General Hospital, MA $16,998
- Uh Cleveland Medical Center, OH $15,820
- Vanderbilt University Medical Center, TN $13,231
- Osf Heart of Mary Medical Center, IL $13,059
- Uofl Health - Jewish Hospital and Mary & Elizabeth Hospital, KY $9,240
- Beth Israel Deaconess Medical Center, MA $7,446
- University of Michigan Health System, MI $6,295
- Mainehealth Maine Medical Center, ME $5,050
- Carolinas Medical Center-Northeast, NC $2,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.