CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,878 enrolled
Drug / intervention
Amulet Left Atrial Appendage Occluder +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02879448
NCT02879448N/ACompleted
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AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial

Abbott Medical Devices·interventional·Posted Aug 25, 2016·Updated Feb 26, 2025

In Brief

A clinical study evaluating Amulet Left Atrial Appendage Occluder and WATCHMAN Left Atrial Appendage Closure for Stroke. Completed, enrolled 1,878 participants across 115 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesAustralia, Canada, Czechia, Denmark, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 25, 2016
Enrollment StartAug 24, 2016
Primary CompletionDec 7, 2020
Study CompletionMay 24, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.9 years ago

Interventions

Amulet Left Atrial Appendage Occluderdevice

Transcatheter left atrial appendage closure

WATCHMAN Left Atrial Appendage Closuredevice

Transcatheter left atrial appendage closure