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
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).
• PFO defined as visualization of microbubbles (during Trans Esophageal Echo (TEE)) in the left atrium within three cardiac cycles of right atrial opacification at rest and/or with Valsalva.
• Cryptogenic stroke defined as a stroke of unknown cause.
• Stroke defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either:
• Symptoms persisting ≥24 hours OR
• Symptoms persisting \<24 hours with Magnetic Resonance Imaging (MRI) or Computer Tomography (CT) findings of a new, neuroanatomically relevant, cerebral infarct.