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.
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).
Study Type
OBSERVATIONAL
Enrollment
582
The Occlutech PFO Occluder is a medical device for transcatheter closure of PFO.
St. Paul's Hospital
Vancouver, Canada
CHU Clermont-Ferrand
Clermont-Ferrand, France
Institut de Cardiologie,groupe hospitalier pitié salpêtrière
Paris, France
To demonstrate the safety and tolerability of the Occlutech PFO occluder by assesssing the incidence of SADEs.
Time frame: in the 1 year following implantation.
To demonstrate the medium-term effectiveness of the Occlutech PFO Occluder by assessing the rate of ischemic strokes.
Time frame: in the 5 years following implantation
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New Civil Hospital
Strasbourg, France
CHU Rangueil
Toulouse, France
Charité Universität Berlin
Berlin, Germany
Herzzentrum Bremen
Bremen, Germany
Klinikum Coburg
Coburg, Germany
Herzzentrum der Universität zu Köln
Cologne, Germany
Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden
Dresden, Germany
...and 7 more locations