Clinical Investigation Comparing Patent Foramen Ovale (PFO) of Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

A PFO Occluder device is a device implanted in the heart to close the PFO to reduce the risk of recurrent stroke or death. The Flex II PFO Occluder investigational device is similar in design to the market approved, current standard of care devices, Amplatzer PFO Occluder and Gore Cardioform PFO Occluder. This study will assess the safety and effectiveness of the Flex II PFO Occluder investigational device in comparison to the market-approved devices. Subjects will be randomized 1:1 to receive either the Flexx II PFO Occluder investigational device or a standard of care PFO Occluder device.

The study is estimated to last up to 5 years (60 months). Upon approval from the U.S. Food and Drug Administration (FDA), subjects will be asked to join a post-approval study to be followed for up to 5 years post procedure.

In order to participate you must meet the following criteria:

• Are 18 years of age or older.
• Have had a cryptogenic stroke defined as a stroke of unknown cause.
• Have an opening in the heart, called a Patent Foramen Ovale (PFO).

You will be excluded from the study if any of the following criteria apply to you:

• Have mitral or aortic valve stenosis or severe regurgitation.
• Have uncontrolled hypertension or diabetes mellitus.
• Have had myocardial infarction or unstable angina within the last 6 months.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.