WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
NCT ID: NCT00129545
Last Updated: 2015-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
800 participants
INTERVENTIONAL
2005-02-28
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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WATCHMAN
Implant of WATCHMAN Left Atrial Appendage Closure Technology
WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Warfarin control
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Warfarin
Subjects receive warfarin
Roll-in
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.
WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Interventions
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WATCHMAN Left Atrial Appendage Closure Technology
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Warfarin
Subjects receive warfarin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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%
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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David Holmes, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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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 D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Bay Heart Group
Tampa, Florida, United States
Emory University Midtown Hospital
Atlanta, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
North Shore University
Evanston, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Prairie Education Research Cooperative
Springfield, Illinois, United States
Baptist Hospital West
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Terrebonne General Medical Center
Houma, Louisiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
William Beaumont
Royal Oak, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Paul Heart Clinic
Saint Paul, Minnesota, United States
University of Mississippi Healthcare Center
Jackson, Mississippi, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
New York University Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Mt. Sinai Medical Center
New York, New York, United States
Summa Health System
Akron, Ohio, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Harrisburg Hospital / Associated Cardiology
Harrisburg, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Presbyterian University Hospital
Pittsburgh, Pennsylvania, United States
Moffitt Heart & Vascular
Wormleysburg, Pennsylvania, United States
Mercy Medical Center West
Knoxville, Tennessee, United States
St. Thomas Research Institute
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia
Austin, Texas, United States
St. Lukes Episcopal Hospital
Houston, Texas, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Na Homolce
Prague, , Czechia
Krankenhaus der Barmherzige Bruder
Regensburg, Bavaria, Germany
Cardiovasculares Centrum Frankfurt - Sankt Katharinen
Frankfurt am Main, Hesse, Germany
Herzzentrum
Leipzig, , Germany
Countries
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References
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Dukkipati SR, Holmes DR Jr, Doshi SK, Kar S, Singh SM, Gibson D, Price MJ, Natale A, Mansour M, Sievert H, Houle VM, Allocco DJ, Reddy VY. Impact of Peridevice Leak on 5-Year Outcomes After Left Atrial Appendage Closure. J Am Coll Cardiol. 2022 Aug 2;80(5):469-483. doi: 10.1016/j.jacc.2022.04.062.
Brouwer TF, Whang W, Kuroki K, Halperin JL, Reddy VY. Net Clinical Benefit of Left Atrial Appendage Closure Versus Warfarin in Patients With Atrial Fibrillation: A Pooled Analysis of the Randomized PROTECT-AF and PREVAIL Studies. J Am Heart Assoc. 2019 Dec 3;8(23):e013525. doi: 10.1161/JAHA.119.013525. Epub 2019 Nov 22.
Price MJ, Reddy VY, Valderrabano M, Halperin JL, Gibson DN, Gordon N, Huber KC, Holmes DR Jr. Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin: A Pooled, Patient-Level Analysis of the WATCHMAN Randomized Trial Experience. JACC Cardiovasc Interv. 2015 Dec 28;8(15):1925-1932. doi: 10.1016/j.jcin.2015.08.035. Epub 2015 Nov 25.
Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
Alli O, Doshi S, Kar S, Reddy V, Sievert H, Mullin C, Swarup V, Whisenant B, Holmes D Jr. Quality of life assessment in the randomized PROTECT AF (Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation) trial of patients at risk for stroke with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2013 Apr 30;61(17):1790-8. doi: 10.1016/j.jacc.2013.01.061. Epub 2013 Feb 28.
Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.
Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011 Feb 1;123(4):417-24. doi: 10.1161/CIRCULATIONAHA.110.976449. Epub 2011 Jan 17.
Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.
Related Links
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Sponsor website
Other Identifiers
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ST1021 and ST1055
Identifier Type: -
Identifier Source: org_study_id
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