To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
Successful transcatheter PFO closure with any approved device
Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
RoPE score <6
Residual shunt ≥moderate following PFO closure
Atrial fibrillation following PFO closure
Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)
Single group
Antiplatelet treatment discontinuation
Other interventionAll patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.
Presence of new stroke events
1)Acute episode of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax or other new neurological symptom(s) consistent with stroke.(2)Duration of a focal or global neurological deficit ≥ 24 hours OR \< 24 hours if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death.
Presence of new ischemic lesions
Evaluated by MRI
Number of new cerebral ischemic lesions
Evaluated by MRI
Volume of new cerebral ischemic lesions
Evaluated by MRI
Number of ischemic events
Stroke, TIA
Number of ischemic events
Stroke, TIA
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Josep Rodes-Cabau
Lead sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor institution
