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 (PROOF)
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Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
Condition or disease
StrokePFO - Patent Foramen Ovale
Device: Occlutech PFO Occluder
This study aims to investigate stroke recurrence rates after interventional PFO closure with an Occlutech PFO Occluder in patients who have experienced at least one ischemic cryptogenic stroke attributed to patent foramen ovale (PFO) who have high risk PFO, i.e. large PFO (≥2 mm), or PFO of any size and atrial septal aneurysm (ASA).
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This study will enroll patients of either sex, aged ≥18 and ≤60 years, with at least one event of cryptogenic ischemic stroke in the last 6 months. Patients must have a high risk PFO indicated for device-assisted closure; either large PFO (≥2 mm), or PFO of any size and ASA.
Age ≥18 years and ≤60 years
At least one event of cryptogenic ischemic stroke in the last 6 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
Known coagulation disorder
Allergies to nickel and/or titanium and/or nickel/titanium-related material, if not medically manageable
Inability to achieve adequate oral anticoagulation therapy and/or platelet inhibition post intervention
Intolerance to contrast agents, if not medically manageable
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
Recent pelvic venous thrombosis
Myocardial infarction or coronary artery bypass surgery within the last 30 days
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
Evidence of drug or alcohol abuse
Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
End-stage heart-, liver-, lung-, or kidney disease
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