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

Phase 2
Completed
Conditions
Atrial Fibrillation
Stroke
Interventions
Device: WATCHMAN Left Atrial Appendage Closure Technology
Registration Number
NCT00129545
Lead Sponsor
Boston Scientific Corporation
Brief Summary

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
800
Inclusion Criteria
  • Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
  • Eligible for long term warfarin
  • CHADS score >= 1 [congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)]
Exclusion Criteria
  • Contraindicated for warfarin
  • Contraindicated for aspirin or clopidogrel (Plavix)
  • Congestive heart failure (CHF) Class 4
  • Implanted mechanical valve
  • Atrial septal or Patent Foramen Ovale (PFO) device
  • Platelets < 100,000 or hemoglobin < 10
  • Left ventricular ejection fraction (LVEF) < 30%

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Roll-inWATCHMAN Left Atrial Appendage Closure TechnologyImplant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
WATCHMANWATCHMAN Left Atrial Appendage Closure TechnologyImplant of WATCHMAN Left Atrial Appendage Closure Technology
Warfarin controlWarfarinSubjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Primary Outcome Measures
NameTimeMethod
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death5 years

A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years)

The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events5 years

Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.

Secondary Outcome Measures
NameTimeMethod
Procedure SuccessInitial implant procedure

Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

Trial Locations

Locations (62)

Advanced Cardiac Specialists

🇺🇸

Gilbert, Arizona, United States

Arizona Arrhythmia

🇺🇸

Scottsdale, Arizona, United States

Foundation for Cardiovascular Medicine

🇺🇸

La Jolla, California, United States

Los Angeles Cardiology Associates

🇺🇸

Los Angeles, California, United States

Cedars-Sinai Medical Center

🇺🇸

Los Angeles, California, United States

El Camino Hospital

🇺🇸

Mountain View, California, United States

Orange County Heart

🇺🇸

Orange County, California, United States

UC Davis Medical Center

🇺🇸

Sacramento, California, United States

St. John's Hospital / Pacific Heart

🇺🇸

Santa Monica, California, United States

Washington Hospital Center

🇺🇸

Washington, District of Columbia, United States

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Advanced Cardiac Specialists
🇺🇸Gilbert, Arizona, United States

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