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

• 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 the Instruction for Use) confirmed by common practice procedures
• A large PFO (maximum separation of the septum primum from the secundum) of ≥2 mm confirmed by common practice procedures, or an ASA defined by common practice procedures 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 being conducted
• Written, informed consent by the patient for participation in the study and agreement 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 platelet inhibition post intervention
• Intolerance to contrast agents
• Participation in another clinical investigation \<30 days before intended Occlutech PFO Occluder implantation procedure (note that in line with Medical Device Reporting, registries are not considered as clinical investigations)
• Contraindication to use of trans-esophageal echocardiography (TEE) and/or use of general 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 cardiac catheterization (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 the implantation,might affect the patients' well-being thereafter or might interfere with the conduct of the study