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AMPLATZER™ Amulet™ LAA Occluder Trial — Amulet IDE  

Stroke Clinical Trial

Official title:
AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial

Clinical Trial Summary

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.

Clinical Trial 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 left atrial appendage (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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02879448
Study type Interventional
Source Abbott Medical Devices
Contact
Status Active, not recruiting
Phase N/A
Start date August 24, 2016
Completion date November 1, 2024
View Details
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