PFO - Patent Foramen Ovale, Stroke
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DEVICEOcclutech PFO Occluder
The Occlutech PFO Occluder is a medical device for transcatheter closure of PFO.
Sponsors
Occlutech International AB
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs. | in the 1 year following implantation. |
| To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic strokes. | in the 5 years following implantation |
Countries
Canada, France, Germany, Italy
Outcome results
None listed