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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129545
Recruitment Status : Completed
First Posted : August 12, 2005
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Device: WATCHMAN Left Atrial Appendage Closure Technology Drug: Warfarin Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)
Study Start Date : February 2005
Actual Primary Completion Date : August 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: WATCHMAN
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Device: WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Other Name: WATCHMAN
Active Comparator: Warfarin control
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Drug: Warfarin
Subjects receive warfarin
Other Name: Coumadin
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.
Device: WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Other Name: WATCHMAN

Primary Outcome Measures :
  1. Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death [ Time Frame: 5 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)

  2. The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events [ Time Frame: 5 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 :
  1. Procedure Success [ Time Frame: Initial implant procedure ]
    Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129545

  Hide Study Locations
United States, Arizona
Advanced Cardiac Specialists
Gilbert, Arizona, United States, 85233
Arizona Arrhythmia
Scottsdale, Arizona, United States, 85251
United States, California
Foundation for Cardiovascular Medicine
La Jolla, California, United States, 92037
Los Angeles Cardiology Associates
Los Angeles, California, United States, 90017
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
El Camino Hospital
Mountain View, California, United States, 94040
Orange County Heart
Orange County, California, United States, 92868
UC Davis Medical Center
Sacramento, California, United States, 95817
St. John's Hospital / Pacific Heart
Santa Monica, California, United States, 90404
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
Bay Heart Group
Tampa, Florida, United States, 33607
United States, Georgia
Emory University Midtown Hospital
Atlanta, Georgia, United States, 30308
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
North Shore University
Evanston, Illinois, United States, 60201
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Prairie Education Research Cooperative
Springfield, Illinois, United States, 60637
United States, Kentucky
Baptist Hospital West
Lexington, Kentucky, United States, 40503
University of Kentucky
Lexington, Kentucky, United States, 40536-0294
United States, Louisiana
Terrebonne General Medical Center
Houma, Louisiana, United States, 70360
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
William Beaumont
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55902
St. Paul Heart Clinic
St. Paul, Minnesota, United States, 55102
United States, Mississippi
University of Mississippi Healthcare Center
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New Mexico
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87102
United States, New York
New York University Medical Center
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
Mt. Sinai Medical Center
New York, New York, United States
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Harrisburg Hospital / Associated Cardiology
Harrisburg, Pennsylvania, United States, 17110
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Presbyterian University Hospital
Pittsburgh, Pennsylvania, United States, 15213
Moffitt Heart & Vascular
Wormleysburg, Pennsylvania, United States, 17043
United States, Tennessee
Mercy Medical Center West
Knoxville, Tennessee, United States, 37934
St. Thomas Research Institute
Nashville, Tennessee, United States
United States, Texas
Texas Cardiac Arrhythmia
Austin, Texas, United States, 78705
St. Lukes Episcopal Hospital
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84107
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Czech Republic
Na Homolce
Prague, Czech Republic, 15030
Krankenhaus der Barmherzige Bruder
Regensburg, Bayern, Germany, 93049
Cardiovasculares Centrum Frankfurt - Sankt Katharinen
Frankfurt am Main, Hessen, Germany, 60389
Leipzig, Germany
Sponsors and Collaborators
Boston Scientific Corporation
Principal Investigator: David Holmes, MD Mayo Clinic

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation Identifier: NCT00129545     History of Changes
Other Study ID Numbers: ST1021 and ST1055
First Posted: August 12, 2005    Key Record Dates
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015
Last Verified: April 2015

Keywords provided by Boston Scientific Corporation:
Atrial Fibrillation
A Fib
Blood thinning medication
transient ischemic attack (TIA)
Left atrial appendage
LAA isolation
LAA occlusion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes