Antiplatelet treatment discontinuation: All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.
Study summary
To determine the safety of antithrombotic treatment discontinuation 12 months following successful transcatheter PFO closure.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Successful transcatheter PFO closure with any approved device
* Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
Exclusion Criteria:
-\>60 year-old
* RoPE score \<6
* Residual shunt ≥moderate following PFO closure
* Atrial fibrillation following PFO closure
* Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)
* Diabetes mellitus
* Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies, lupus anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency, protein S deficiency)
* Recurrent cerebrovascular event (stroke, TIA) within the year following PFO closure
* Failure to provide signed informed consent
* Absolute contraindications for an MRI study
Primary outcome measure(s)
Presence of new stroke events — 12 months 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 — 24-month follow-up Evaluated by MRI
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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