AMPLATZER™ Amulet™ LAA Occluder Trial "Amulet IDE"

Recruiting

Phase N/A Results N/A

Trial Description

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 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

Interventions

  • Amulet Left Atrial Appendage Occluder Device
    Intervention Desc: Transcatheter left atrial appendage closure
    ARM 1: Kind: Experimental
    Label: Amulet
    Description: Amulet left atrial appendage occluder
  • WATCHMAN Left Atrial Appendage Closure Device
    Intervention Desc: Transcatheter left atrial appendage closure
    ARM 1: Kind: Experimental
    Label: WATCHMAN (Control)
    Description: WATCHMAN left atrial appendage closure device

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Procedure-related complications, all-cause death, major bleeding 12-month Yes
Primary Ischemic stroke, systemic embolism 18-month No
Primary Device closure 45-days No
Secondary All stroke, systemic embolism, or cardiovascular/unexplained death 18-month No
Secondary Major bleeding post-device implant 18-month No

Sponsors