AMPLATZER™ Amulet™ LAA Occluder Trial "Amulet IDE"

Recruiting

Phase N/A Results N/A

Summary of Purpose

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.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 15 November 2017.

1 Aug 2016 22 Aug 2016 1 Feb 2020 1 Dec 2023 1 Nov 2017 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Contacts