Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion (NCT05069558) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
United States450 participantsStarted 2022-05-09
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria: Subjects with a PFO and cryptogenic stroke:
* 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.
Exclusion Criteria:
* Age \< 18 years
* Myocardial Infarction (MI) or unstable angina within 6 months.
* Severe mitral valve stenosis, severe aortic valve stenosis, or severe regurgitation.
* Left Ventricle Ejection Fraction (LVEF) \<35%.
* Uncontrolled hypertension or diabetes mellitus despite medications.
* Subjects contraindicated for aspirin or clopidogrel.
* 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.
* Anatomy in which the device would interfere with intracardiac or vascular structures.
* Life expectancy \< 2 years.
* Participation in another clini…