The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO

Inclusion Criteria:

• Age ≥18 years and ≤65 years

• At least one event of cryptogenic ischemic stroke in the last 12 months

• Presence of a PFO indicated for device-assisted closure (in compliance with theInstruction for Use) confirmed by common practice procedures

• A large PFO (maximum separation of the septum primum from the secundum) of ≥2 mmconfirmed by common practice procedures, or an ASA defined by common practiceprocedures as septum primum excursion of ≥10 mm

• Life expectancy of at least 1 year

• Ability to speak fluently and to understand the language in which the study is beingconducted

• Written, informed consent by the patient for participation in the study andagreement to comply with the follow-up schedule

Exclusion Criteria:

• Acute infection(s)

• Known coagulation disorder

• Arrhythmia

• Atrial Tumor

• Allergies to nickel and/or titanium and/or nickel/titanium-related material

• Inability to achieve adequate oral anticoagulation therapy and/or plateletinhibition post intervention

• Intolerance to contrast agents

• Participation in another clinical investigation <30 days before intended OcclutechPFO Occluder implantation procedure (note that in line with Medical DeviceReporting, registries are not considered as clinical investigations)

• Contraindication to use of trans-esophageal echocardiography (TEE) and/or use ofgeneral anesthetic

• Eisenmenger Syndrome

• Recent pelvic venous thrombosis

• Myocardial infarction or coronary artery bypass surgery within the last 30 days

• Atrial thrombus

• Patients whose size or condition would cause them to be a poor candidate for cardiaccatheterization (e.g. too small for echocardiography imaging probe, catheter size,vasculature size, active infection, body weight <8 kg)

The following exclusion criteria are at the discretion of the investigator:

• Stroke of any other origin

• Large artery atherosclerosis

• Small vessel disease

• Arterial dissection

• Hypercoagulable disorder

• Uncontrolled hypertension

• Uncontrolled diabetes

• Autoimmune disease

• Evidence of drug or alcohol abuse

• Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter

• End-stage heart-, liver-, lung-, or kidney disease

• Cardiac tumor

• Endocarditis or septicemia

• Severe valvular pathology

• Any condition that, in the opinion of the investigator, might interfere with theimplantation,might affect the patients' well-being thereafter or might interferewith the conduct of the study