Amulet™ ADVANCE LAA

Study Overview
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Brief Summary
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This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. The study will enroll approximately 1000 subjects at up to 50 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.

Detailed Description
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The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device in the United States. The Amulet device is intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

Official Title
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A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder

Conditions
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Atrial Fibrillation, Stroke, Bleeding

Intervention / Treatment
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* Device: Left atrial appendage occlusion (LAAO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intended for LAAO with the Amulet device At least 18 years of age Willing and capable of providing informed consent and participating in all testing associated with this clinical study Exclusion Criteria: Presence of other conditions that, in the investigator's opinion, could limit the subject's ability to participate in follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Left atrial appendage occlusion (LAAO)|Implantation of an Amplatzer Amulet left atrial appendage occluder|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint: Death or complications | Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later | Within 7 days of implant or hospital discharge, whichever is later | 
| Device closure, defined as residual jet around the device ≤ 3mm | Device closure (defined as residual jet around the device ≤ 3mm) at the first follow-up visit documented by trans-esophageal echocardiography (TEE), as assessed by an independent core laboratory | Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant. | 
| Composite endpoint: Ischemic stroke or systemic embolism | Composite of ischemic stroke or systemic embolism through 24 months | Through 24 months |