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

Completed

Phase 2/3 Results

Trial Description

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.

Detailed Description

The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Other Names: Coumadin; Acenocoumarol
    Intervention Desc: Subjects receive warfarin
    ARM 1: Kind: Experimental
    Label: Warfarin control
    Description: Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
  • WATCHMAN® device Other
    Intervention Desc: The WATCHMAN® device is designed to keep harmful sized blood clots that form in the left atrial appendage from entering your blood stream, potentially causing a stroke. It is made of materials that are common to many medical devices. The WATCHMAN device is designed to be permanently placed just behind or at the opening of the left atrial appendage.
  • WATCHMAN Left Atrial Appendage Closure Technology Device
    Other Names: WATCHMAN
    Intervention Desc: Implant of WATCHMAN Left Atrial Appendage Closure Technology
    ARM 1: Kind: Experimental
    Label: Implantable device
    Description: Implantable WATCHMAN Left ATrial Appendage Occlusion Device
    ARM 2: Kind: Experimental
    Label: WATCHMAN
    Description: Implant of WATCHMAN Left Atrial Appendage Closure Technology
    ARM 3: Kind: Experimental
    Label: Roll-in
    Description: Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.

Trial Design

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

Patient Involvement

Baseline testing for patients consists of medical history, TEE and coagulation testing. Follow-up of patients will be done at 45 days, 6, 9, and 12 months and semi-annually thereafter.

Outcomes

Type Measure Time Frame Safety Issue
Primary All stroke; systemic embolism; cardiovascular mortality.
Secondary Technical success; procedure success; 30 day major adverse event (MAE); left atrial appendage (LAA) coverage.
Primary All stroke 5 years Yes
Primary Systemic embolism 5 years No
Primary Cardiovascular death 5 years No
Secondary Technical success 45 days No
Secondary Procedure success 45 days No
Secondary 30 day major adverse event (MAE) 30 days Yes
Secondary Left atrial appendage (LAA) coverage 45 days No
Primary Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death 5 years No
Primary The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events 5 years Yes

Sponsors