Last updated on March 2019

AMPLATZER Amulet LAA Occluder Trial


Brief description of study

The Amulet device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

Detailed Study Description

The Amulet IDE trial is a prospective, randomized, multi-center active control worldwide trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device (treatment) or a Boston Scientific WATCHMAN LAA closure device (Control). The trial will be conducted at up to 150 sites worldwide. All enrolled subjects will follow the protocol-required tests and assessments at each scheduled follow-up visit.

Clinical Study Identifier: NCT02879448

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PRAXISKLINIK Herz und Gef e

Dresden, Germany
5.15miles

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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