NCT02879448

AMPLATZER™ Amulet™ LAA Occluder Trial

AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,878 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Amulet Left Atrial Appendage Occluder	Transcatheter left atrial appendage closure
DEVICE	WATCHMAN Left Atrial Appendage Closure	Transcatheter left atrial appendage closure

Timeline

• Start date: 2016-08-24
• Primary completion: 2020-12-07
• Completion: 2024-05-24
• First posted: 2016-08-25
• Last updated: 2025-02-26
• Results posted: 2022-01-11

Locations

115 sites across 11 countries: United States, Australia, Canada, Czechia, Denmark, Germany, Italy, Netherlands, Portugal, Spain, Switzerland