AMPLATZER™ LAA Occluder Post Approval Study (PAS)

Study Overview
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Brief Summary
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The AMPLATZER LAA Occluder is a transcatheter, self-expanding nitinol device intended for use in preventing thrombus embolization from the LAA. The purpose of this study is to compile real world outcome data on the use of AMPLATZER LAA Occluder in subjects with non-valvular atrial fibrillation (NVAF)

Detailed Description
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The AMPLATZER LAA Occluder device will be clinically evaluated through this post approval study. This is a non-randomized multicenter study on patients who have undergone a procedure to implant an AMPLATZER LAA Occluder or will undergo an implant of an AMPLATZER LAA Occluder.

Official Title
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AMPLATZER™ LAA Occluder Post Approval Study (PAS)

Conditions
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Atrial Fibrillation, Thromboembolism, Stroke

Intervention / Treatment
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* Device: AMPLATZER™ LAA Occluder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Documented history of nonvalvular atrial fibrillation Subjects in whom an AMPLATZER LAA Occluder device is intended to be implanted or Subjects who underwent an AMPLATZER LAA Occluder implant attempt after the device was approved in the applicable geography Exclusion Criteria: Women of childbearing potential who are, or plan to become, pregnant during the time of the study

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: AMPLATZER™ LAA Occluder|The AMPLATZER™ LAA Occluder is intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular Atrial Fibrillation (AF). It may be considered for use in patients who have a high risk of stroke and bleeding and are deemed by their physician to have an appropriate rationale to seek a non-pharmacologic alternative to long term anticoagulants.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of one or more adverse events listed in description below | The occurrence of one or more the composite of stroke (including ischemic or hemorrhagic), systemic embolism, or cardiovascular or unexplained death at 24 months from the time of enrollment | Implant through 24 months | 
| The occurrence of ischemic stroke or systemic embolism as listed in description below. | The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment | Implant through 24 months | 
| The occurrence of a major adverse event within 7 days | The occurrence of one of the following events between the time of implant and within 7 days of the procedure or by hospital discharge, whichever is later: all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular repair | Implant through 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the observed rate of ischemic stroke at 24months with the CHA2DS2-VASc predicted rate |  | Implant through 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Thromboembolism, Stroke, ACP, Left Atrial Appendage, Cardiac Plug, Amulet, Amplatzer