Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban

Not yet recruiting

Phase 4 Results N/A

Trial Description

This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular atrial fibrillation.

Conditions

Interventions

  • Rivaroxaban Drug
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: Subjects assigned to receive the Rivaroxaban therapy.
  • WATCHMAN Left Atrial Appendage Occlusion Device Device
    Other Names: WATCHMAN Left Atrial Appendage Closure
    ARM 1: Kind: Experimental
    Label: WATCHMAN LAA Occlusion Device
    Description: Subjects assigned to receive the WATCHMAN Left Atrial Appendage Occlusion 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 Combined endpoint 1 year No
Secondary All bleeding event 1 year Yes
Secondary Major bleeding event 1 year Yes
Secondary Technical and procedure related event 45 days Yes
Secondary Cognitive function change 1 year No

Sponsors