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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00129545
First received: August 10, 2005
Last updated: September 23, 2013
Last verified: September 2013
  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.


Condition Intervention Phase
Atrial Fibrillation
Stroke
Device: WATCHMAN Left Atrial Appendage Closure Technology
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • All stroke [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Systemic embolism [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Cardiovascular death [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Technical success [ Time Frame: 45 days ] [ Designated as safety issue: No ]
  • Procedure success [ Time Frame: 45 days ] [ Designated as safety issue: No ]
  • 30 day major adverse event (MAE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Left atrial appendage (LAA) coverage [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1550
Study Start Date: February 2005
Estimated Study Completion Date: January 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implantable device
Implantable WATCHMAN Left ATrial Appendage Occlusion Device
Device: WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Other Name: WATCHMAN

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  • 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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129545

  Hide Study Locations
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
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Los Angeles Cardiology Associates
Los Angeles, California, United States, 90017
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
Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
University of Miami
Miami, Florida, United States, 33136
Bay Heart Group
Tampa, Florida, United States, 33607
United States, Georgia
Emory University Midtown Hospital
Atlanta, Georgia, United States, 30308
Emory University Hospital
Atlanta, Georgia, United States, 30322
Piedmont Hospital
Atlanta, Georgia, United States, 30309
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
University of Kentucky
Lexington, Kentucky, United States, 40536-0294
Baptist Hospital West
Lexington, Kentucky, United States, 40503
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
Columbia University Medical Center
New York, New York, United States, 10032
New York University Medical Center
New York, New York, United States, 10016
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
Presbyterian University Hospital
Pittsburgh, Pennsylvania, United States, 15213
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
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
Germany
Krankenhaus der Barmherzige Bruder
Regensburg, Bayern, Germany, 93049
Cardiovasculares Centrum Frankfurt - Sankt Katharinen
Frankfurt am Main, Hessen, Germany, 60389
Herzzentrum
Leipzig, Germany
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: David Holmes, MD Mayo Clinic
  More Information

Additional Information:
No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00129545     History of Changes
Other Study ID Numbers: ST1021 and ST1055
Study First Received: August 10, 2005
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Atrial Fibrillation
AF
A Fib
Stroke
Coumadin
Warfarin
Blood thinning medication
TIA
WATCHMAN
Left atrial appendage
LAA isolation
LAA occlusion

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014