Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Closure With the LAmbre Device in Patients With Nonvalvular Atrial Fibrillation: A Multinational Real-world Registry
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: All criteria must be met * 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 who has undergone a successful LAmbre LAAC device implantation with no complications during the in-hospital period after the intervention and * Patient able and willing to return for required follow-up visits and examinations and * Patient with Informed consent signed. Exclusion Criteria: No exclusion criteria must be met. * 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 ex