WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

Completed

Phase 2/3 Results

Summary of Purpose

This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 29 April 2015.

1 Feb 2005 10 Aug 2005 1 Aug 2013 1 May 2014 1 Apr 2015 3 Oct 2014
Start Date First Received 1st Completion Completion Verification Results

Trial Basics

Interventions

Conditions

Sponsors

Trial Design

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

Contacts

  • Andrea Stone, BS Phone: 763.746.5005 Email: astone@atritech.net Linn L Laak, BS Phone: 763.746.5026 Email: llaak@atritech.net

    astone@atritech.net