Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4000 participants
INTERVENTIONAL
2023-11-30
2029-12-01
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
TREATMENT
SINGLE
Study Groups
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WATCHMAN device
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
WATCHMAN device
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Standard Care
Participants will receive local, standard medical care
No interventions assigned to this group
Interventions
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WATCHMAN device
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Eligibility Criteria
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Inclusion Criteria
2. Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. \[Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).\]
3. Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial.
Exclusion Criteria
2. Current left atrial appendage thrombus
3. Prior left atrial appendage occlusion or removal (surgical or percutaneous)
4. Prior percutaneous atrial septal defect or patent foramen ovale closure
5. Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
6. Planned atrial fibrillation ablation within 90 days of enrollment
7. Individuals being treated with direct thrombin inhibitors
8. Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
9. Anticipated life-expectancy of \< 2 years
10. Patient unable or willing to give informed consent
18 Years
ALL
No
Sponsors
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McMaster University
OTHER
Population Health Research Institute
OTHER
Boston Scientific Corporation
INDUSTRY
Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Principal Investigators
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Jeff Healey
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Locations
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Affinity Hospital dba Grandview Medical Center
Birmingham, Alabama, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Memorial Health Services
Fountain Valley, California, United States
Loma Linda University Health
Loma Linda, California, United States
Sutter Valley Hospitals dba Sutter Institute for Medical Research
Sacramento, California, United States
St. Vincent's Health System
Jacksonville, Florida, United States
The University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
St Luke's Regional Medical Center, Ltd
Boise, Idaho, United States
Kootenai Health Inc.
Coeur d'Alene, Idaho, United States
Northwestern University
Evanston, Illinois, United States
Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island
Rock Island, Illinois, United States
Community Health Network Inc.
Indianapolis, Indiana, United States
MercyOne Iowa Heart Center
West Des Moines, Iowa, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Babtist Health Lexington
Lexington, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
Lahey Clinic Inc.
Burlington, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
The Feinstein Institutes for Medical Research
Manhasset, New York, United States
Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian Hospital
New York, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
Mission Hospital HCA
Asheville, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
TriHealth Inc.
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular Institute
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Glanecare, Inc. d/b/a HCA Florida Brandon Hospital
Brentwood, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
Heart Rhythm Associates
The Woodlands, Texas, United States
CHRISTUS Northeast Texas Health System
Tyler, Texas, United States
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, United States
CommonSpirit Health Research Institute
Tacoma, Washington, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Imeldaziekenhuis
Bonheiden, Antwerpen, Belgium
AZORG vzw and Hartcentrum Aalst
Aalst, East-Flanders, Belgium
ASBL CHU Helora - Hôpital de La Louvière - site Jolimont
La Louvière, Hainaut, Belgium
CHR de la Citadelle
Liège, Liège, Belgium
AZ Glorieux
Ronse, Oost-Vlaanderen, Belgium
AZ Delta VZW
Roeselare, West-Vlaanderen, Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
University of Calgary
Calgary, Alberta, Canada
Vancouver Coastal Health Authority
Vancouver, British Columbia, Canada
St. Boniface Hospital Inc.
Winnipeg, Manitoba, Canada
Circulate Cardiac & Vascular Centre (CCVC)
Burlington, Ontario, Canada
Cambridge Cardiac Care Inc.
Cambridge, Ontario, Canada
Hamilton Health Sciences Corp
Hamilton, Ontario, Canada
Research St. Joseph's - Hamilton
Hamilton, Ontario, Canada
Waterloo Wellington Cardiovascular Research Institute (WWCRI)
Kitchener, Ontario, Canada
Lawson Health Research Institute
London, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Partners in Advanced Cardiac Evaluation (PACE)
Newmarket, Ontario, Canada
Ottawa Heart Institute Research Corp
Ottawa, Ontario, Canada
Niagara Health System - Niagara Falls
St. Catharines, Ontario, Canada
Niagara Health Systems - St. Catharines
St. Catharines, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Lawrence Park Cardiology
Toronto, Ontario, Canada
Unity Health Toronto
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal (ICM)
Montreal, Quebec, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, Canada
Prairie Valscular Research Inc. (PVRI)
Regina, Saskatchewan, Canada
Saskatchewan Health Authority
Saskatoon, Saskatchewan, Canada
Region Hospital Viborg
Viborg, Central Jutland, Denmark
Aarhus University Hospital (AUH)
Aarhus, Region Midt, Denmark
Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark
Esbjerg, Region Syddanmark, Denmark
North Denmark Regional Hospital
Hjørring, , Denmark
Odense Universitets Hospital
Odense C, , Denmark
Infirmerie Protestante de Lyon
Caluire-et-Cuire, Auvergne-Rhône-Alpes, France
Clinique Pasteur
Toulouse, Occitanie, France
Hôpital Bichat
Paris, , France
European Georges Pompidou Hospital
Paris, , France
Centre Cardiologique due Nord
Saint-Denis, , France
Städtisches Klinikum Karsruhe gGmbH
Karlsruhe, Baden-Wurttemberg, Germany
CVC Rhein-Main GmbH
Frankfurt am Main, Hesse, Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt am Main, Hesse, Germany
Johann Wolfgang Goethe Universität Franfurt - Universitätsklinikum Franfurt
Frankfurt am Main, Hesse, Germany
Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH
Bad Oeynhausen, North Rhine-Westphalia, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, Rhineland-Palatinate, Germany
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany
Universitätsklinikum Schleswig - Holstein
Lübeck, Schleswig-Holstein, Germany
Katholisches Krankenhaus "St. Johann Nepomuk"
Erfurt, Thuringia, Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, , Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, , Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, , Italy
American Heart of Poland SA
Ustroń, , Poland
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Complejo Asistencial Universitario de León
León, , Spain
Universitario La Luz - Grupo Quirónsalud
Madrid, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, West Midlands, United Kingdom
University Hospitals Sussex NHS Trust
Worthing, West Sussex, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Countries
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Central Contacts
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References
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Grifoni E, Pagni B, Sansone T, Baldini M, Bertini E, Giannoni S, Di Donato I, Sivieri I, Iandoli G, Mannini M, Giglio E, Vescera V, Brai E, Signorini I, Cosentino E, Micheletti I, Cioni E, Pelagalli G, Dei A, Giordano A, Dainelli F, Romagnoli M, Mattaliano C, Schipani E, Murgida GS, Di Martino S, Francolini V, Masotti L. Clinical Features, Management, and Recurrence of Acute Ischemic Stroke Occurring in Patients on Oral Anticoagulant Treatment for Nonvalvular Atrial Fibrillation: A Real-World Retrospective Study. Neurologist. 2024 Nov 1;29(6):329-338. doi: 10.1097/NRL.0000000000000579.
Other Identifiers
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LAAOS-4
Identifier Type: -
Identifier Source: org_study_id