Actively Recruiting
Led by Hamilton Health Sciences Corporation · Updated on 2026-06-08
4000
Participants Needed
140
Research Sites
13 weeks
Total Duration
H
Hamilton Health Sciences Corporation
Lead Sponsor
M
McMaster University
Collaborating Sponsor
Researchers are investigating whether using a catheter-based endovascular device called the WATCHMAN to close off the left atrial appendage can help prevent ischemic stroke or systemic embolism in people with atrial fibrillation who remain at high risk of stroke despite ongoing treatment with oral blood thinners. This study is a multicenter, randomized controlled trial with an open-label design but with blinded assessment of results to ensure unbiased evaluation. Participants will be randomly assigned to either receive the left atrial appendage occlusion with the WATCHMAN device or continue their standard medical care without the device. Those in the device group will undergo the procedure to close off the left atrial appendage using the WATCHMAN device. Both groups will continue their oral anticoagulant treatment as prescribed. The study will continue until 265 primary events of ischemic stroke or systemic embolism occur, with an average follow-up estimated at about 4 years. Throughout the study, participants will be monitored for occurrences of ischemic stroke, systemic embolism, transient ischemic attacks, cognitive function using the Montreal Cognitive Assessment, cardiovascular and all-cause mortality, and new disabling ischemic strokes. Safety and effectiveness will be assessed during the event-driven study period. Participants will be followed for approximately 4 years on average to gather the necessary outcome data and ensure ongoing monitoring of their health status.
CONDITIONS
The Fourth Left Atrial Appendage Occlusion Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Event-driven until study completion, estimated average follow-up of 4 years
Participants undergo endovascular left atrial appendage occlusion with the WATCHMAN device.
Duration - Event-driven until study completion, estimated average follow-up of 4 years
Participants are monitored for ischemic stroke, systemic embolism, and other outcomes after the procedure or during standard care.
Total: 140 locations
1
Affinity Hospital dba Grandview Medical Center
Birmingham, Alabama, United States, 35243
Withdrawn
2
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
3
Memorial Health Services
Fountain Valley, California, United States, 92708
Actively Recruiting
4
Loma Linda University Health
Loma Linda, California, United States, 92354
Actively Recruiting
5
Southern California Permanente Medical Group
Pasadena, California, United States, 91101
Actively Recruiting
6
Sutter Valley Hospitals dba Sutter Institute for Medical Research
Sacramento, California, United States, 95816
Actively Recruiting
7
JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital
Atlantis, Florida, United States, 33462
Actively Recruiting
8
St. Vincent's Health System
Jacksonville, Florida, United States, 32204
Actively Recruiting
9
Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center
Largo, Florida, United States, 33770
Actively Recruiting
10
HCA Florida Ocala Hospital
Ocala, Florida, United States, 34471
Actively Recruiting
11
The University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
12
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
13
St Luke's Regional Medical Center, Ltd
Boise, Idaho, United States, 83712
Actively Recruiting
14
Kootenai Health Inc.
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
15
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
16
Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island
Rock Island, Illinois, United States, 61201
Actively Recruiting
17
Community Health Network Inc.
Indianapolis, Indiana, United States, 46256
Actively Recruiting
18
MercyOne Iowa Heart Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
19
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States, 66160
Actively Recruiting
20
Babtist Health Lexington
Lexington, Kentucky, United States, 40503
Actively Recruiting
21
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
22
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
23
Lahey Clinic Inc.
Burlington, Massachusetts, United States, 01805
Actively Recruiting
24
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
25
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
26
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
27
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
28
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
29
Presbyterian Healthcare Services d.b.a. Presbyterian Heart Group
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
30
The Feinstein Institutes for Medical Research
Manhasset, New York, United States, 11030
Actively Recruiting
31
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, 10065
Actively Recruiting
32
NYU Grossman School of Medicine
New York, New York, United States, 10065
Withdrawn
33
Mission Hospital HCA
Asheville, North Carolina, United States, 28801
Actively Recruiting
34
Aultman Hospital
Canton, Ohio, United States, 44710
Actively Recruiting
35
TriHealth Inc.
Cincinnati, Ohio, United States, 45202
Actively Recruiting
36
University of Cincinnati
Cincinnati, Ohio, United States, 45221
Actively Recruiting
37
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
38
Saint Francis Hospital
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
39
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
40
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
41
University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular Institute
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
42
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
43
Glanecare, Inc. d/b/a HCA Florida Brandon Hospital
Brentwood, Tennessee, United States, 37027
Actively Recruiting
44
The University of Tennessee
Memphis, Tennessee, United States, 38163
Actively Recruiting
45
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Withdrawn
46
Baylor Research Institute
Dallas, Texas, United States, 75204
Actively Recruiting
47
Heart Rhythm Associates
The Woodlands, Texas, United States, 77380
Withdrawn
48
CHRISTUS Northeast Texas Health System
Tyler, Texas, United States, 75701-2263
Actively Recruiting
49
The Rector and Visitors of the University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
50
CommonSpirit Health Research Institute
Tacoma, Washington, United States, 98405
Actively Recruiting
51
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
52
Imeldaziekenhuis
Bonheiden, Antwerpen, Belgium, 2820
Actively Recruiting
53
AZORG vzw and Hartcentrum Aalst
Aalst, East-Flanders, Belgium, 9300
Actively Recruiting
54
ASBL CHU Helora - Hôpital de La Louvière - site Jolimont
La Louvière, Hainaut, Belgium, 7100
Actively Recruiting
55
CHR de la Citadelle
Liège, Liège, Belgium, 4000
Actively Recruiting
56
AZ Glorieux
Ronse, Oost-Vlaanderen, Belgium, 9600
Actively Recruiting
57
AZ Sint Jan Brugge AV
Bruges, West-Vlaanderen, Belgium, 8000
Actively Recruiting
58
AZ Delta VZW
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
59
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Actively Recruiting
60
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
61
Vancouver Coastal Health Authority
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
62
St. Boniface Hospital Inc.
Winnipeg, Manitoba, Canada, R2H 2A6
Actively Recruiting
63
Circulate Cardiac & Vascular Centre (CCVC)
Burlington, Ontario, Canada, L7M 1K9
Actively Recruiting
64
Cambridge Cardiac Care Inc.
Cambridge, Ontario, Canada, N1R 6V6
Actively Recruiting
65
Hamilton Health Sciences Corp
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
66
Research St. Joseph's - Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
67
Waterloo Wellington Cardiovascular Research Institute (WWCRI)
Kitchener, Ontario, Canada, N2M 5N6
Actively Recruiting
68
Lawson Health Research Institute
London, Ontario, Canada, N6A 2R5
Actively Recruiting
69
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L2Y 2P9
Actively Recruiting
70
Partners in Advanced Cardiac Evaluation (PACE)
Newmarket, Ontario, Canada, L3Y 2P6
Actively Recruiting
71
Ottawa Heart Institute Research Corp
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
72
Niagara Health System - Niagara Falls
St. Catharines, Ontario, Canada, L2S 0A9
Actively Recruiting
73
Niagara Health Systems - St. Catharines
St. Catharines, Ontario, Canada, L2S 0A9
Actively Recruiting
74
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
75
Lawrence Park Cardiology
Toronto, Ontario, Canada, M4N 3N1
Actively Recruiting
76
Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
77
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
78
Institut de Cardiologie de Montreal (ICM)
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
79
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X OC1
Actively Recruiting
80
Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
81
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, J1J 3H5
Actively Recruiting
82
Prairie Valscular Research Inc. (PVRI)
Regina, Saskatchewan, Canada, S4P 0W5
Actively Recruiting
83
Saskatchewan Health Authority
Saskatoon, Saskatchewan, Canada, S7K 0M7
Actively Recruiting
84
Region Hospital Viborg
Viborg, Central Jutland, Denmark, 8800
Actively Recruiting
85
Aarhus University Hospital (AUH)
Aarhus, Region Midt, Denmark, 8200
Actively Recruiting
86
Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark
Esbjerg, Region Syddanmark, Denmark, 6700
Actively Recruiting
87
Rigshospitalet (RH)
Copenhagen, Denmark, 2100
Actively Recruiting
88
North Denmark Regional Hospital
Hjørring, Denmark, 9800
Actively Recruiting
89
Odense Universitets Hospital
Odense C, Denmark, 4500
Actively Recruiting
90
Infirmerie Protestante de Lyon
Caluire-et-Cuire, Auvergne-Rhône-Alpes, France, 69300
Actively Recruiting
91
CHU Saint Etienne
Saint-Etienne, Auvergne-Rhône-Alpes, France, 42055
Actively Recruiting
92
Centre Hospitalier Régional Universitaire de Tours
Tours, Centre-Val de Loire, France, 37044
Actively Recruiting
93
CHR Metz-Thionville / Hôpital de MERCY
Ars-Laquenexy, Moselle, France
Actively Recruiting
94
Centre Hospitalier Universitaire de Toulouse
Toulouse, Occitanie, France, 31059
Actively Recruiting
95
Clinique Pasteur
Toulouse, Occitanie, France, 31076
Actively Recruiting
96
SCP des Médecins Cardiologues
Toulouse, Occitanie, France, 31076
Actively Recruiting
97
The Fondation de l'AP-HP
Paris, Paris, France, 75012
Actively Recruiting
98
L'Assistance Publique-Hôpitaux de Marseille
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
Actively Recruiting
99
Hôpital Pitie Salpétrière
Paris, France, 75013
Actively Recruiting
100
Institut Médico-chirurgical Montsouris
Paris, France, 75014
Actively Recruiting
101
Hôpital Bichat
Paris, France, 75018
Actively Recruiting
102
European Georges Pompidou Hospital
Paris, France, 75908
Actively Recruiting
103
Hospital Prive Jacques Cartier
Massy, Île-de-France Region, France, 91300
Actively Recruiting
104
Centre Cardiologique due Nord
Saint-Denis, Île-de-France Region, France, 93200
Actively Recruiting
105
Städtisches Klinikum Karsruhe gGmbH
Karlsruhe, Baden-Wurttemberg, Germany, 76133
Actively Recruiting
106
Kardiovaskulaeres Zentrum Darmstadt
Darmstadt, Hesse, Germany, 64287
Actively Recruiting
107
CVC Rhein-Main GmbH
Frankfurt am Main, Hesse, Germany, 60389
Actively Recruiting
108
MVZ CCB Frankfurt und Main-Taunus GbR
Frankfurt am Main, Hesse, Germany, 60431
Actively Recruiting
109
Johann Wolfgang Goethe Universität Franfurt - Universitätsklinikum Franfurt
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
110
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, Germany, D-18057
Actively Recruiting
111
Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Actively Recruiting
112
Westpfalz-Klinikum GmbH
Kaiserslautern, Rhineland-Palatinate, Germany, 67665
Actively Recruiting
113
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany, 04289
Actively Recruiting
114
Heinrich-Braun-Klinikum gemeinnützige GmbH
Zwickau, Saxony, Germany, 08060
Actively Recruiting
115
Universitätsklinikum Schleswig - Holstein
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
116
Katholisches Krankenhaus "St. Johann Nepomuk"
Erfurt, Thuringia, Germany, 99097
Actively Recruiting
117
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Actively Recruiting
118
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12203
Actively Recruiting
119
Asklepios Kliniken Hamburg GmbH
Hamburg, Germany, 20099
Actively Recruiting
120
Asklepios Kliniken Hamburg GmbH
Hamburg, Germany, 20099
Actively Recruiting
121
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany, 20246
Actively Recruiting
122
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
123
Azienda Ospedaliero Universitaria Sassari
Sassari, Sassari, Italy, 07100
Actively Recruiting
124
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Actively Recruiting
125
Stichting Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands, 5623EJ
Actively Recruiting
126
Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego
Warsaw, Masovian Voivodeship, Poland, 04-628
Actively Recruiting
127
American Heart of Poland SA
Ustroń, Poland, 43-450
Actively Recruiting
128
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain, 36312
Actively Recruiting
129
University General Hospital Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
130
Complejo Asistencial Universitario de León
León, Spain, 24071
Actively Recruiting
131
Universitario La Luz - Grupo Quirónsalud
Madrid, Spain, 28003
Actively Recruiting
132
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47003
Actively Recruiting
133
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
134
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE1 5WW
Actively Recruiting
135
Nottingham University Hospital NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Actively Recruiting
136
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
137
University Hospitals Coventry and Warwickshire
Coventry, West Midlands, United Kingdom, CV2 2DX
Actively Recruiting
138
University Hospitals Sussex NHS Trust
Worthing, West Sussex, United Kingdom, BN11 2DH
Actively Recruiting
139
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom, L14 3PE
Actively Recruiting
140
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
P
Program Director
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Elisa Grifoni, Beatrice Pagni, Teresa Sansone...
https://pubmed.ncbi.nlm.nih.gov/39344366