ClinicaliQ Trial Snapshot
- Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion — Active Not Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT05069558.
- Occlutech Flex II PFO occluder shows non-inferiority to standard devices for closing heart defects and preventing recurrent stroke.
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What This Trial Is Studying
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). Conditions: Stroke, Patent Foramen Ovale, PFO Interventions: Investigational PFO Closure Device, Standard of Care PFO Closure Device Lead Sponsor: Occlutech International AB Planned Enrollment: 450 participants