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AMPLATZER™ Amulet™ LAA Occluder Trial

NCT02879448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1878

Last updated 2025-02-26

Study results available
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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.

Conditions

Interventions

DEVICE

Amulet Left Atrial Appendage Occluder

Transcatheter left atrial appendage closure

DEVICE

WATCHMAN Left Atrial Appendage Closure

Transcatheter left atrial appendage closure

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Dhanunjaya Lakkireddy, MD · University of Kansas

  • David Thaler, MD, PhD · The Comprehensive Stroke Center at Tufts Medical Center

  • Stephan Windecker, MD, PhD · Inselspital, University of Bern

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-24
Primary Completion
2020-12-07
Completion
2024-05-24

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02879448 on ClinicalTrials.gov