The Fourth Left Atrial Appendage Occlusion Study
Start Date
11/30/2023
Completion Date
12/1/2029
Summary
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Detailed Description
LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
WATCHMAN device
Conditions
Locations
Affinity Hospital dba Grandview Medical Center
Birmingham, Alabama 35243
United States
Arrhythmia Research Group
Jonesboro, Arkansas 72401
United States
Memorial Health Services
Fountain Valley, California 92708
United States
Loma Linda University Health
Loma Linda, California 92354
United States
Southern California Permanente Medical Group
Pasadena, California 91101
United States
Sutter Valley Hospitals dba Sutter Institute for Medical Research
Sacramento, California 95816
United States
JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital
Atlantis, Florida 33462
United States
St. Vincent's Health System
Jacksonville, Florida 32204
United States
Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center
Largo, Florida 33770
United States
HCA Florida Ocala Hospital
Ocala, Florida 34471
United States
The University of South Florida
Tampa, Florida 33620
United States
Emory University
Atlanta, Georgia 30322
United States
St Luke's Regional Medical Center, Ltd
Boise, Idaho 83712
United States
Kootenai Health Inc.
Coeur d'Alene, Idaho 83814
United States
Northwestern University
Evanston, Illinois 60208
United States
Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island
Rock Island, Illinois 61201
United States
Community Health Network Inc.
Indianapolis, Indiana 46256
United States
MercyOne Iowa Heart Center
West Des Moines, Iowa 50266
United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160
United States
Babtist Health Lexington
Lexington, Kentucky 40503
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
University of Maryland Baltimore
Baltimore, Maryland 21201
United States
Lahey Clinic Inc.
Burlington, Massachusetts 01805
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Presbyterian Healthcare Services d.b.a. Presbyterian Heart Group
Albuquerque, New Mexico 87106
United States
The Feinstein Institutes for Medical Research
Manhasset, New York 11030
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 10065
United States
NYU Grossman School of Medicine
New York, New York 10065
United States
Mission Hospital HCA
Asheville, North Carolina 28801
United States
Aultman Hospital
Canton, Ohio 44710
United States
TriHealth Inc.
Cincinnati, Ohio 45202
United States
University of Cincinnati
Cincinnati, Ohio 45221
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Saint Francis Hospital
Tulsa, Oklahoma 74136
United States
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular Institute
Pittsburgh, Pennsylvania 15213
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Glanecare, Inc. d/b/a HCA Florida Brandon Hospital
Brentwood, Tennessee 37027
United States
The University of Tennessee
Memphis, Tennessee 38163
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
United States
Baylor Research Institute
Dallas, Texas 75204
United States
Heart Rhythm Associates
The Woodlands, Texas 77380
United States
CHRISTUS Northeast Texas Health System
Tyler, Texas 75701-2263
United States
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia 22903
United States
CommonSpirit Health Research Institute
Tacoma, Washington 98405
United States
The Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Imeldaziekenhuis
Bonheiden, Antwerpen 2820
Belgium
AZORG vzw and Hartcentrum Aalst
Aalst, East-Flanders 9300
Belgium
ASBL CHU Helora - Hôpital de La Louvière - site Jolimont
La Louvière, Hainaut 7100
Belgium
CHR de la Citadelle
Liège, Liège 4000
Belgium
AZ Glorieux
Ronse, Oost-Vlaanderen 9600
Belgium
AZ Sint Jan Brugge AV
Bruges, West-Vlaanderen 8000
Belgium
AZ Delta VZW
Roeselare, West-Vlaanderen 8800
Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090
Belgium
University of Calgary
Calgary, Alberta T2N 1N4
Canada
Vancouver Coastal Health Authority
Vancouver, British Columbia V5Z 1M9
Canada
St. Boniface Hospital Inc.
Winnipeg, Manitoba R2H 2A6
Canada
Circulate Cardiac & Vascular Centre (CCVC)
Burlington, Ontario L7M 1K9
Canada
Cambridge Cardiac Care Inc.
Cambridge, Ontario N1R 6V6
Canada
Hamilton Health Sciences Corp
Hamilton, Ontario L8L 2X2
Canada
Research St. Joseph's - Hamilton
Hamilton, Ontario L8N 4A6
Canada
Waterloo Wellington Cardiovascular Research Institute (WWCRI)
Kitchener, Ontario N2M 5N6
Canada
Lawson Health Research Institute
London, Ontario N6A 2R5
Canada
Southlake Regional Health Centre
Newmarket, Ontario L2Y 2P9
Canada
Partners in Advanced Cardiac Evaluation (PACE)
Newmarket, Ontario L3Y 2P6
Canada
Ottawa Heart Institute Research Corp
Ottawa, Ontario K1Y 4W7
Canada
Niagara Health System - Niagara Falls
St. Catharines, Ontario L2S 0A9
Canada
Niagara Health Systems - St. Catharines
St. Catharines, Ontario L2S 0A9
Canada
Sunnybrook Health Sciences Center
Toronto, Ontario M4N 3M5
Canada
Lawrence Park Cardiology
Toronto, Ontario M4N 3N1
Canada
Unity Health Toronto
Toronto, Ontario M5B 1W8
Canada
University Health Network
Toronto, Ontario M5G 2C4
Canada
Institut de Cardiologie de Montreal (ICM)
Montreal, Quebec H1T 1C8
Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec H2X OC1
Canada
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec G1V 4G5
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 J1J 3H5
Canada
Prairie Valscular Research Inc. (PVRI)
Regina, Saskatchewan S4P 0W5
Canada
Saskatchewan Health Authority
Saskatoon, Saskatchewan S7K 0M7
Canada
Region Hospital Viborg
Viborg, Central Jutland 8800
Denmark
Aarhus University Hospital (AUH)
Aarhus, Region Midt 8200
Denmark
Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark
Esbjerg, Region Syddanmark 6700
Denmark
Rigshospitalet (RH)
Copenhagen, 2100
Denmark
North Denmark Regional Hospital
Hjørring, 9800
Denmark
Odense Universitets Hospital
Odense C, 4500
Denmark
Infirmerie Protestante de Lyon
Caluire-et-Cuire, Auvergne-Rhône-Alpes 69300
France
CHU Saint Etienne
Saint-Etienne, Auvergne-Rhône-Alpes 42055
France
Centre Hospitalier Régional Universitaire de Tours
Tours, Centre-Val de Loire 37044
France
CHR Metz-Thionville / Hôpital de MERCY
Ars-Laquenexy, Moselle
France
Centre Hospitalier Universitaire de Toulouse
Toulouse, Occitanie 31059
France
Clinique Pasteur
Toulouse, Occitanie 31076
France
SCP des Médecins Cardiologues
Toulouse, Occitanie 31076
France
The Fondation de l'AP-HP
Paris, Paris 75012
France
L'Assistance Publique-Hôpitaux de Marseille
Marseille, Provence-Alpes-Côte d'Azur Region 13005
France
Hôpital Pitie Salpétrière
Paris, 75013
France
Institut Médico-chirurgical Montsouris
Paris, 75014
France
Hôpital Bichat
Paris, 75018
France
European Georges Pompidou Hospital
Paris, 75908
France
Hospital Prive Jacques Cartier
Massy, Île-de-France Region 91300
France
Centre Cardiologique due Nord
Saint-Denis, Île-de-France Region 93200
France
Städtisches Klinikum Karsruhe gGmbH
Karlsruhe, Baden-Wurttemberg 76133
Germany
Kardiovaskulaeres Zentrum Darmstadt
Darmstadt, Hesse 64287
Germany
CVC Rhein-Main GmbH
Frankfurt am Main, Hesse 60389
Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt am Main, Hesse 60431
Germany
Johann Wolfgang Goethe Universität Franfurt - Universitätsklinikum Franfurt
Frankfurt am Main, Hesse 60590
Germany
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern D-18057
Germany
Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH
Bad Oeynhausen, North Rhine-Westphalia 32545
Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, Rhineland-Palatinate 67665
Germany
Herzzentrum Leipzig GmbH
Leipzig, Saxony 04289
Germany
Heinrich-Braun-Klinikum gemeinnützige GmbH
Zwickau, Saxony 08060
Germany
Universitätsklinikum Schleswig - Holstein
Lübeck, Schleswig-Holstein 23538
Germany
Katholisches Krankenhaus "St. Johann Nepomuk"
Erfurt, Thuringia 99097
Germany
Charité Universitätsmedizin Berlin
Berlin, 10117
Germany
Charité - Universitätsmedizin Berlin
Berlin, 12203
Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, 20099
Germany
Asklepios Kliniken Hamburg GmbH
Hamburg, 20099
Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120
Germany
Azienda Ospedaliero Universitaria Sassari
Sassari, Sassari 07100
Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124
Italy
Stichting Catharina Ziekenhuis
Eindhoven, North Brabant 5623EJ
Netherlands
Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego
Warsaw, Masovian Voivodeship 04-628
Poland
American Heart of Poland SA
Ustroń, 43-450
Poland
Hospital Álvaro Cunqueiro
Vigo, Pontevedra 36312
Spain
University General Hospital Dr. Balmis
Alicante, 03010
Spain
Complejo Asistencial Universitario de León
León, 24071
Spain
Universitario La Luz - Grupo Quirónsalud
Madrid, 28003
Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Spain
Universitätsspital Basel
Basel, Canton of Basel-City 4031
Switzerland
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire LE1 5WW
United Kingdom
Nottingham University Hospital NHS Trust
Nottingham, Nottinghamshire NG5 1PB
United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire OX3 9DU
United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, West Midlands CV2 2DX
United Kingdom
University Hospitals Sussex NHS Trust
Worthing, West Sussex BN11 2DH
United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, L14 3PE
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
United Kingdom