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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Stroke, Patent Foramen Ovale

Intervention / Treatment
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* Device: Investigational PFO Closure Device
* Device: Standard of Care PFO Closure Device


Participation Criteria
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Eligibility Criteria
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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: Minimum Age: 18 Years and Maximum Age: ≥50 years. Myocardial Infarction (MI) or unstable angina within 6 months. Mitral or 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. Subjects not able to discontinue anticoagulation. Qualifying stroke with Modified Rankin score >3. Anatomy in which the device would interfere with intracardiac or vascular structures. Life expectancy < 2 years. Exclusion for patients with known causes of ischemic stroke: 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: Lupus anticoagulant, anticardiolipin Abs, hyperhomocysteinemia, Cancer-related hypercoagulability. 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. 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). Arterial dissection as the qualifying event.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational PFO Closure Device<br>PFO closure with the study Occlutech Flex II PFO device. | Device: Investigational PFO Closure Device<br>* Occlutech Flex II PFO Closure Device<br>|
| Active Comparator: Standard of Care PFO Closure Device<br>PFO closure with either of the standard of care PFO occlusion devices; Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder. | Device: Standard of Care PFO Closure Device<br>* Amplatzer PFO Occluder and Gore Cardioform PFO Occluder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Closure Rate of PFO |  | Twelve Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Fatal Recurrent Stroke |  | Enrollment to 12 Months |