Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

Other illness

• Myocardial Infarction (MI) or unstable angina within 6 months.
• Uncontrolled hypertension or diabetes mellitus despite medications.
• Presence of other comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results.
• Qualifying stroke with Modified Rankin score \>3.
• Exclusion for patients with known causes of ischemic stroke:
• Lacunar infarct probably due to intrinsic small vessel as the qualifying event, defined as an ischemic stroke in the distribution of a single, small deep penetrating vessel in a patient with any of the following:
• A history of hypertension (except in the first week post stroke).
• A history of diabetes mellitus.

Lab values

• Left Ventricle Ejection Fraction (LVEF) \<35%.

Age

• Age \< 18 years
• Life expectancy \< 2 years.
• Age ≥50 years.
• MRI or CT with leukoaraiosis greater than symmetric, well-defined periventricular caps, or bands (European Task Force on Age-Related White Matter Changes rating scale score \>0).

Other

• Severe mitral valve stenosis, severe aortic valve stenosis, or severe regurgitation.
• Subjects contraindicated for aspirin or clopidogrel.
• Anatomy in which the device would interfere with intracardiac or vascular structures.
• Participation in another clinical study that can interfere with the results of this study
• Atrial fibrillation/atrial flutter (chronic or intermittent).
• Left Ventricle (LV) aneurysm, intracardiac thrombus, or tumor.
• Mitral or aortic valve vegetation or prosthesis.
• Aortic arch plaques protruding \>4 mm into the lumen.
• Atherosclerosis or arteriopathy of intra- or extracranial vessels with \>50% diameter stenosis in the artery supplying the infarcted territory.
• Another cause of right-to-left shunting (e.g., an Atrial Septal Defect (ASD) or a fenestrated atrial septum).
• Presence of an arterial hypercoagulable state.
• Arterial dissection as the qualifying event.

• 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.