Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study

This is a prospective and retrospective, multicenter observational study where the study is being performed to explore on the short-term and long-term safety and efficacy of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population on a real-world basis.

Inclusion Criteria:18 year of age or olderDocumented paroxysmal, persistent, or permanent non-valvular atrial fibrillationAt high risk of stroke or systemic embolism defined as CHA2DS2-VASc score of more than or equal to 3Deemed suitable for LAA occlusion by the treating physician, who might or might not be the investigatorAble to comply with the required medication regimen post-device implantAble and willing to return for required follow-up visits and examinationsExclusion Criteria:With active endocarditis or other infections producing bacteremiaWhere placement of the device would interfere with any intracardiac or intravascular structuresReversible cause of AF (i.e. secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)Hypersensitivity to any portion of the device material or individual components of the Amulet LAA closure deviceActively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trialPresence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requireemnts, or impact the scientific soundness of the clinical trial results.