Atrial fibrillation is a cardiac arrhythmia associated with increased risk of stroke and systemic embolism. Apixaban, an oral anticoagulant, and the Watchman, a left atrial appendage closure device, are the currently used therapeutic treatments for the prevention of stroke and systemic embolism in atrial fibrillation patients. However, a direct comparison of these two treatments with respect to safety and effectiveness remains limited. This research evaluates Apixaban and the Watchman device by analysing the clinical trial data and full regulatory approval pathways. Apixaban has been approved through New Drug Application process, and the Watchman device is approved via the premarket approval process. The study highlights the quality and rigorous nature of the New Drug Application and the premarket approval process, indicating the safety and efficacy of Apixaban and the Watchman device. This research emphasizes the need for individualised treatment decisions for atrial fibrillation patients.
","abstract_html":"<p>Atrial fibrillation is a cardiac arrhythmia associated with increased risk of stroke and systemic embolism. Apixaban, an oral anticoagulant, and the Watchman, a left atrial appendage closure device, are the currently used therapeutic treatments for the prevention of stroke and systemic embolism in atrial fibrillation patients. However, a direct comparison of these two treatments with respect to safety and effectiveness remains limited. This research evaluates Apixaban and the Watchman device by analysing the clinical trial data and full regulatory approval pathways. Apixaban has been approved through New Drug Application process, and the Watchman device is approved via the premarket approval process. The study highlights the quality and rigorous nature of the New Drug Application and the premarket approval process, indicating the safety and efficacy of Apixaban and the Watchman device. This research emphasizes the need for individualised treatment decisions for atrial fibrillation patients.</p>","abstract_has_math":false,"creators":["Konatham, Sreeja"],"institution":null,"degree_name":"Master of Science (MS)","degree_level":"Open Access Thesis","degree_discipline":"Health Sciences","degree_department":null,"school":null,"contributors":["Michael Switzer, Ph.D.","Shannon Murray, MHS"],"advisors":[],"committee_chairs":[],"committee_members":[],"year":2025,"date_issued":"2025-01-01T08:00:00Z","date_published":"2025-01-01T08:00:00Z","updated_at":"2026-07-24T02:17:53Z","subjects":["Apixaban","Left Atrial Appendage","NDA","PMA","Watchman","Watchman Device","Medicine and Health Sciences","Surgery"],"languages":[],"rights":[],"rights_urls":[],"identifier_entries":[]},"links":{"outbound_url":"https://commons.emich.edu/theses/1300","outbound_label":"Repository record","outbound_source":"dc:identifier"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor","label":"Contributor","values":["Michael Switzer, Ph.D.","Shannon Murray, MHS"]},{"key":"dc:creator","label":"Author","values":["Konatham, Sreeja"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:date.available","label":"Dc Date Available","values":["2025-06-19T07:00:00Z"]},{"key":"thesis:degree_discipline","label":"Discipline","values":["Health Sciences"]},{"key":"thesis:degree_level","label":"Degree Level","values":["Open Access Thesis"]},{"key":"thesis:degree_name","label":"Degree Name","values":["Master of Science (MS)"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["Apixaban","Left Atrial Appendage","NDA","PMA","Watchman","Watchman Device","Medicine and Health Sciences","Surgery"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier","label":"Identifier","values":["https://commons.emich.edu/theses/1300"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description.abstract","label":"Abstract","values":["Atrial fibrillation is a cardiac arrhythmia associated with increased risk of stroke and systemic embolism. Apixaban, an oral anticoagulant, and the Watchman, a left atrial appendage closure device, are the currently used therapeutic treatments for the prevention of stroke and systemic embolism in atrial fibrillation patients. However, a direct comparison of these two treatments with respect to safety and effectiveness remains limited. This research evaluates Apixaban and the Watchman device by analysing the clinical trial data and full regulatory approval pathways. Apixaban has been approved through New Drug Application process, and the Watchman device is approved via the premarket approval process. The study highlights the quality and rigorous nature of the New Drug Application and the premarket approval process, indicating the safety and efficacy of Apixaban and the Watchman device. This research emphasizes the need for individualised treatment decisions for atrial fibrillation patients.
"]},{"key":"dc:title","label":"Title","values":["Comparison of Apixaban and left atrial appendage exclusion device (Watchman) in preventing stroke and systemic embolism in atrial fibrillation patients"]}]}],"canonical_facts":{"dc:contributor":["Michael Switzer, Ph.D.","Shannon Murray, MHS"],"dc:creator":["Konatham, Sreeja"],"dc:date.available":["2025-06-19T07:00:00Z"],"dc:description.abstract":["Atrial fibrillation is a cardiac arrhythmia associated with increased risk of stroke and systemic embolism. Apixaban, an oral anticoagulant, and the Watchman, a left atrial appendage closure device, are the currently used therapeutic treatments for the prevention of stroke and systemic embolism in atrial fibrillation patients. However, a direct comparison of these two treatments with respect to safety and effectiveness remains limited. This research evaluates Apixaban and the Watchman device by analysing the clinical trial data and full regulatory approval pathways. Apixaban has been approved through New Drug Application process, and the Watchman device is approved via the premarket approval process. The study highlights the quality and rigorous nature of the New Drug Application and the premarket approval process, indicating the safety and efficacy of Apixaban and the Watchman device. This research emphasizes the need for individualised treatment decisions for atrial fibrillation patients.
"],"dc:identifier":["https://commons.emich.edu/theses/1300"],"dc:subject":["Apixaban","Left Atrial Appendage","NDA","PMA","Watchman","Watchman Device","Medicine and Health Sciences","Surgery"],"dc:title":["Comparison of Apixaban and left atrial appendage exclusion device (Watchman) in preventing stroke and systemic embolism in atrial fibrillation patients"],"thesis:degree_discipline":["Health Sciences"],"thesis:degree_level":["Open Access Thesis"],"thesis:degree_name":["Master of Science (MS)"]},"updated_at":"2026-07-24T02:17:53Z"}