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

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 orsevere 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 nocomplications during the in-hospital period after the intervention and

• Patient able and willing to return for required follow-up visits and examinationsand

• Patient with Informed consent signed.

Exclusion Criteria:

No exclusion criteria must be met.

• Patient is currently enrolled in another investigational study, except when thesubject is participating in a purely observational registry with no associatedtreatments.

• Patient requires long-term anticoagulation therapy for reasons other than AFrelatedstroke risk reduction, for example, due to an underlying hypercoagulable state (i.eeven if the device is implanted, the subjects would not be eligible to discontinueOAC (Oral Anticoagulation) due to other medical conditions requiring chronic OACtherapy).

• 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 notbe eligible to discontinue aspirin or clopidogrel due to other medical conditionsrequiring this therapy.

• Patient had or is planning to have any cardiac or noncardiac intervention orsurgical procedure within 30 days before or 60 days after implant (including, butnot limited to: cardioversion, PCI (Percutaneous Coronary Intervention), cardiacablation, cataract surgery, etc.).

• Patient had a prior stroke (of any cause, whether ischemic or hemorrhagic) ortransient ischemic attack (TIA) within the 30 days prior to enrollment.

• Patient had a major bleeding event within the 30 days prior to inclusion. Lack ofresolution of related clinical sequelae or planned and pending interventions toresolve bleeding/bleeding source are further exclusions, regardless of the timing ofthe bleeding event.

• Patient has an active bleeding.

• Patient has had an MI documented in the clinical record as either a NSTEMI or STEMI,with or without intervention, within 30 days prior to enrollment.

• Patient has a history of atrial septal repair or has an ASD/PFO device.

• Patient is of childbearing potential, or plans to become pregnant during the study (method of assessment upon study physician's discretion).

• Patient had subject has a documented life expectancy of less than one year.