Brief Summary: A prospective, multicenter, single-arm, non-randomized study including consecutive patients with nonvalvular AF(Atrial Fibrillation), with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women), and contraindication for long-term anticoagulant treatment, with successful LAAC (Left Atrial Appendage Closure)procedure with the LAmbre device, who at discharge are eligible for short-term (3-months-only) SAPT. We want to assess if a short-term single antiplatelet therapeutic regime of Acetylsalicylic acid (ASA) 100 mg (or clopidogrel 75 mg if ASA contraindication), once daily, for 3 months is safe and effective at 12 months follow-up.
Patient 18 years and over and
Patient with documented nonvalvular AF, defined as AF in the absence of moderate or severe mitral stenosis or a mechanical heart valve and
Patient with a calculated CHA₂DS₂-VASc score ≥2 (for men) and ≥3 (for women) and
Patient with a contraindication for long-term anticoagulant treatment and
Patient is currently enrolled in another investigational study, except when the subject is participating in a purely observational registry with no associated treatments.
Patient requires long-term anticoagulation therapy for reasons other than AFrelated stroke risk reduction, for example, due to an underlying hypercoagulable state (i.e even if the device is implanted, the subjects would not be eligible to discontinue OAC (Oral Anticoagulation) due to other medical conditions requiring chronic OAC therapy).
Patient has contraindications or is allergic to both aspirin and clopidogrel.
Patient has an indication for chronic aspirin or clopidogrel treatment (i.e., chronic ischemic disease or peripheral artery disease); thus, the subject would not be eligible to discontinue aspirin or clopidogrel due to other medical conditions requiring this therapy.
patients with nonvalvular AF, with a CHA₂DS₂-VASc score ≥2 (men) or ≥3 (women), contraindication for long-term anticoagulant treatment, with implantation procedural success of LAAC with the LAmbre device, who at discharge are eligible for short-term (3-months-only) SAPT
Case-only
Prospective
Single antiplatelet therapy (SAPT)
DrugObservational study of effectiveness and safety of SAPT (either with acetyl-salycilic acid or clopidogrel) after LAAO with Lambre device in patients with high risk of bleeding
Composite of stroke
A composite of stroke (including ischemic and/or hemorrhagic) and/or systemic embolism
Device thrombosis
Freedom from device thrombosis by Echocardiography (TEE), confirmed by a cardiac Computed Tomography (CT) scan
Device thrombosis
Freedom from device thrombosis by Transesophageal Echocardiography (TEE), confirmed by a cardiac Computed Tomography (CT) scan
Cardiovascular death
Freedom of Cardiovascular death
Major bleeding
Freedom from major bleeding events according to Academy Consortium \[BARC\] ≥3b)
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