Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral

Inclusion Criteria

• •Cardioembolic\* Ischemic stroke despite OAC or DOAC within the last 6 months.
• •Documented AF (either valvular or non-valvular AF).
• •LAA suitable for closure (if LAA thrombus, just distal).
• •Functional status at inclusion with no severe disability (mRS\<4).
• •No contraindication for LAA assessment by CT or 3D-TEE.
• •\>18 years
• •Life expectancy \>1year
• •Able to understand written consent prior to the trial inclusion.
• •Able and willing to return for follow-up visits and tests.
• •Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following randomization, other than study-related procedures such as LAAO and cardiac imaging (if applicable).
• •In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure.
• •Non-treated patent foramen ovale (PFO) or PFO closure device implanted.
• •Inferior vena cava filter.
• •Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the ICE probe (if planned) or required catheters, or subject has - active infection or bleeding disorder).
• •Customary contraindications for TEE/TOE (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer).
• •Underwent catheter ablation for AF or atrial flutter within 60 days prior to randomization.
• •Experienced myocardial infarction within 90 days prior to randomization.
• •New York Heart Association Class IV Congestive Heart Failure.
• •Left ventricular ejection fraction ≤ 30% (per most recent assessment).
• •LAA is obliterated or surgically ligated.
• •Thrombocytopenia (defined as \< 50,000 platelets per microliter (\<50 x 109/L) or anemia (defined as hemoglobin \< 10 g/dL) requiring transfusions.
• •Hypersensitivity to any portion of the device material or individual components of the Amulet LAA occluder device (e.g., nickel allergy).
• •Allergy to contrast media if the patient needs angio-CT and cannot undergo TEE/TOE.
• •Actively enrolled in, or plans to enroll in, a concurrent clinical study in which the active treatment arm may confound the results of this trial.
• •Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation.
• •Active endocarditis or other infection producing bacteremia.
• •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the subject's ability to participate in clinical investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results.