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)
Inclusion Criteria
- PFO defined as visualization of microbubbles (during 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 MR or CT findings of a new neuroanatomically relevant, cerebral infarct.
Exclusion Criteria
- MI or unstable angina within 6 months
- Mitral or aortic valve stenosis or severe regurgitation
- Exclusion for patients with known causes of ischemic stroke: atrial fibrillation/atrial flutter (chronic or intermittent)
Study Requirements
Baseline screening visit:
• Medical History
• Diagnosis of a cryptogenic stroke by the neurologist
• Diagnosis of a PFO by the cardiologist
• Hypercoagulable state blood draw
Procedure:
• PFO implant procedure data collection
1-month & 6-month follow-up:
• Stroke Assessment
• Adverse Event collection
12-month follow-up:
• Stroke Assessment
• TTE Echo to determine effective closure
• Adverse event collection
Long-term follow-up:
• Annual visits until PMA Approval
• Stroke assessment
• Adverse event collection
