AMPLATZER™ LAA Occluder Post Approval Study (PAS)

Recruiting

Phase N/A Results N/A

Trial Description

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

The AMPLATZER LAA Occluder device will be clinically evaluated through this post approval study. This is a prospective, multicenter, non-randomized observational post-approval study, on patients who will undergo an implant of the AMPLATZER LAA Occluder.

Conditions

Interventions

  • AMPLATZER™ Cardiac Plug™ LAA Occluder Device
    Other Names: Amplatzer Cardiac Plug
    Intervention Desc: 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.

Trial Population

The subject population will include participants that are > 18 years old and diagnosed with NVAF.

Outcomes

Type Measure Time Frame Safety Issue
Primary The occurrence of one or more adverse events listed in description below Implant through 24 months
Primary The occurrence of ischemic stroke or systemic embolism as listed in description below. Implant through 24 months
Primary The occurrence of a major adverse event within 7 days Implant through 7 days
Secondary Comparison of the observed rate of ischemic stroke or systemic embolism at 24months with the CHA2DS2-VASc predicted rate Implant through 24 months

Sponsors