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El cuarto estudio de oclusión del apéndice auricular izquierdo (LAAOS-4)

15 de septiembre de 2026 actualizado por: Hamilton Health Sciences Corporation

El cuarto estudio de oclusión del apéndice auricular izquierdo (LAAOS-4)

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.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

4000

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Program Director
  • Número de teléfono: 905-521-2100
  • Correo electrónico: LAAOS-4@phri.ca

Ubicaciones de estudio

      • Berlin, Alemania, 12203
        • Reclutamiento
        • Charité - Universitätsmedizin Berlin
        • Investigador principal:
          • Carsten Skurk, MD
      • Berlin, Alemania, 10117
        • Reclutamiento
        • Charité Universitätsmedizin Berlin
        • Investigador principal:
          • Leif-Hendrik Boldt, MD
      • Hamburg, Alemania, 20246
        • Reclutamiento
        • Universitätsklinikum Hamburg-Eppendorf (UKE)
        • Investigador principal:
          • Andreas Metzner, Prof., MD
      • Hamburg, Alemania, 20099
        • Reclutamiento
        • Asklepios Kliniken Hamburg GmbH
        • Investigador principal:
          • Martin Bergmann, MD
        • Investigador principal:
          • Arian Sultan, MD
      • Heidelberg, Alemania, 69120
        • Reclutamiento
        • Universitätsklinikum Heidelberg
        • Investigador principal:
          • Farbod Sedaghat-Hamedani, MD
    • Baden-Wurttemberg
      • Karlsruhe, Baden-Wurttemberg, Alemania, 76133
        • Reclutamiento
        • Städtisches Klinikum Karsruhe gGmbH
        • Investigador principal:
          • Armin Luik, Prof., MD
    • Hesse
      • Darmstadt, Hesse, Alemania, 64287
        • Reclutamiento
        • Kardiovaskulaeres Zentrum Darmstadt
        • Investigador principal:
          • Jörg Honold, MD
      • Frankfurt am Main, Hesse, Alemania, 60389
        • Reclutamiento
        • CVC Rhein-Main GmbH
        • Investigador principal:
          • Horst Sievert, MD
      • Frankfurt am Main, Hesse, Alemania, 60431
        • Reclutamiento
        • MVZ CCB Frankfurt und Main-Taunus GbR
        • Investigador principal:
          • Boris Schmidt, MD
      • Frankfurt am Main, Hesse, Alemania, 60590
        • Reclutamiento
        • Johann Wolfgang Goethe Universität Franfurt - Universitätsklinikum Franfurt
        • Investigador principal:
          • Reza Wakili, MD
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Alemania, D-18057
        • Reclutamiento
        • Universitätsmedizin Rostock
        • Investigador principal:
          • Hueseyin Ince, Prof., MD
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Alemania, 32545
        • Reclutamiento
        • Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH
        • Investigador principal:
          • Werner Scholtz, MD
      • Cologne, North Rhine-Westphalia, Alemania, 50937
        • Reclutamiento
        • Universitätsklinikum Köln (AöR)
        • Investigador principal:
          • Daniel Steven, Prof., MD
    • Rhineland-Palatinate
      • Kaiserslautern, Rhineland-Palatinate, Alemania, 67665
        • Reclutamiento
        • Westpfalz-Klinikum GmbH
        • Investigador principal:
          • Burghard Schumacher, MD
    • Saxony
      • Leipzig, Saxony, Alemania, 04289
        • Reclutamiento
        • Herzzentrum Leipzig GmbH
        • Investigador principal:
          • Marcus Sandri, MD
      • Zwickau, Saxony, Alemania, 08060
        • Reclutamiento
        • Heinrich-Braun-Klinikum gemeinnützige GmbH
        • Investigador principal:
          • Holger H. Sigusch, MD
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Alemania, 23538
        • Reclutamiento
        • Universitätsklinikum Schleswig - Holstein
        • Investigador principal:
          • Ingo Eitel, MD
    • Thuringia
      • Erfurt, Thuringia, Alemania, 99097
        • Reclutamiento
        • Katholisches Krankenhaus "St. Johann Nepomuk"
        • Investigador principal:
          • Henning Ebelt, MD
      • Brussels, Bélgica, 1090
        • Reclutamiento
        • Universitair Ziekenhuis Brussel
        • Investigador principal:
          • Stijn Lochy, MD
      • Liège, Bélgica, 4000
        • Reclutamiento
        • CHR de la Citadelle
        • Investigador principal:
          • Jean-Manuel Herzet, MD
    • Antwerpen
      • Bonheiden, Antwerpen, Bélgica, 2820
        • Reclutamiento
        • Imeldaziekenhuis
        • Investigador principal:
          • Philippe Debruyne, MD
    • East-Flanders
      • Aalst, East-Flanders, Bélgica, 9300
        • Reclutamiento
        • AZORG vzw and Hartcentrum Aalst
        • Investigador principal:
          • Tom De Potter, MD
    • Hainaut
      • La Louvière, Hainaut, Bélgica, 7100
        • Reclutamiento
        • ASBL CHU Helora - Hôpital de La Louvière - site Jolimont
        • Investigador principal:
          • Antoine de Meester, MD
    • Oost-Vlaanderen
      • Ronse, Oost-Vlaanderen, Bélgica, 9600
        • Reclutamiento
        • AZ Glorieux
        • Investigador principal:
          • Becker Alzand, MD
    • West-Vlaanderen
      • Bruges, West-Vlaanderen, Bélgica, 8000
        • Reclutamiento
        • AZ Sint Jan Brugge AV
        • Investigador principal:
          • Ian Buysschaert, MD
      • Roeselare, West-Vlaanderen, Bélgica, 8800
        • Reclutamiento
        • AZ Delta VZW
        • Investigador principal:
          • Maarten Vanhaverbeke, MD
    • Alberta
      • Calgary, Alberta, Canadá, T2N 1N4
        • Reclutamiento
        • University of Calgary
        • Investigador principal:
          • Stephen Wilton, MD
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 1M9
        • Reclutamiento
        • Vancouver Coastal Health Authority
        • Investigador principal:
          • Jason Andrade, MD
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R2H 2A6
        • Reclutamiento
        • St. Boniface Hospital Inc.
        • Investigador principal:
          • Malek Kass, MD
    • Ontario
      • Burlington, Ontario, Canadá, L7M 1K9
        • Reclutamiento
        • Circulate Cardiac & Vascular Centre (CCVC)
        • Investigador principal:
          • Hisham Dokainish, MD
      • Cambridge, Ontario, Canadá, N1R 6V6
        • Reclutamiento
        • Cambridge Cardiac Care Inc.
        • Investigador principal:
          • A. Shekhar Pandey, MD
      • Hamilton, Ontario, Canadá, L8N 4A6
        • Reclutamiento
        • Research St. Joseph's - Hamilton
        • Investigador principal:
          • Vikas Tandon, MD
      • Hamilton, Ontario, Canadá, L8L 2X2
        • Reclutamiento
        • Hamilton Health Sciences Corp
        • Investigador principal:
          • Guy Amit, MD
      • Kitchener, Ontario, Canadá, N2M 5N6
        • Reclutamiento
        • Waterloo Wellington Cardiovascular Research Institute (WWCRI)
        • Investigador principal:
          • Umjeet Jolly, MD
      • London, Ontario, Canadá, N6A 2R5
        • Reclutamiento
        • Lawson Health Research Institute
        • Investigador principal:
          • Allan Skanes, MD
      • Newmarket, Ontario, Canadá, L2Y 2P9
        • Reclutamiento
        • Southlake Regional Health Centre
        • Investigador principal:
          • Mouhannad Sadek, MD
      • Newmarket, Ontario, Canadá, L3Y 2P6
        • Reclutamiento
        • Partners in Advanced Cardiac Evaluation (PACE)
        • Investigador principal:
          • Yaariv Khaykin, MD
      • Ottawa, Ontario, Canadá, K1Y 4W7
        • Reclutamiento
        • Ottawa Heart Institute Research Corp
        • Investigador principal:
          • Omar Abdel-Razek, MD
      • St. Catharines, Ontario, Canadá, L2S 0A9
        • Reclutamiento
        • Niagara Health Systems - St. Catharines
        • Investigador principal:
          • Nigel Tan, MD
      • St. Catharines, Ontario, Canadá, L2S 0A9
        • Retirado
        • Niagara Health System - Niagara Falls
      • Toronto, Ontario, Canadá, M4N 3M5
        • Reclutamiento
        • Sunnybrook Health Sciences Center
        • Investigador principal:
          • Sheldon Singh, MD
      • Toronto, Ontario, Canadá, M5G 2C4
        • Reclutamiento
        • University Health Network
        • Investigador principal:
          • Eric Horlick, MD
      • Toronto, Ontario, Canadá, M4N 3N1
        • Reclutamiento
        • Lawrence Park Cardiology
        • Investigador principal:
          • Eugene Crystal, MD
      • Toronto, Ontario, Canadá, M5B 1W8
        • Reclutamiento
        • Unity Health Toronto
        • Investigador principal:
          • Neil Fam, MD
    • Quebec
      • Montreal, Quebec, Canadá, H1T 1C8
        • Reclutamiento
        • Institut de Cardiologie de Montreal (ICM)
        • Investigador principal:
          • Reda Ibrahim, MD
      • Montreal, Quebec, Canadá, H2X OC1
        • Reclutamiento
        • Centre hospitalier de l'Université de Montréal
        • Investigador principal:
          • Jean-Marc Raymond, MD
      • Québec, Quebec, Canadá, G1V 4G5
        • Reclutamiento
        • Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval
        • Investigador principal:
          • Jean Champagne, MD
      • Sherbrooke, Quebec, Canadá, J1J 3H5
        • Reclutamiento
        • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
        • Investigador principal:
          • Charles Dussault, MD
    • Saskatchewan
      • Regina, Saskatchewan, Canadá, S4P 0W5
        • Reclutamiento
        • Prairie Valscular Research Inc. (PVRI)
        • Investigador principal:
          • Payam Dehghani, MD
      • Saskatoon, Saskatchewan, Canadá, S7K 0M7
        • Reclutamiento
        • Saskatchewan Health Authority
        • Investigador principal:
          • Stephan Wardell, MD
      • Copenhagen, Dinamarca, 2100
        • Reclutamiento
        • Rigshospitalet (RH)
        • Investigador principal:
          • Ole De Backer, MD
      • Hjørring, Dinamarca, 9800
        • Reclutamiento
        • North Denmark Regional Hospital
        • Investigador principal:
          • Albert Marni Joensen, MD
      • Odense C, Dinamarca, 4500
        • Reclutamiento
        • Odense Universitets Hospital
        • Investigador principal:
          • Mikkel Hougaard, MD
    • Central Jutland
      • Viborg, Central Jutland, Dinamarca, 8800
        • Reclutamiento
        • Region Hospital Viborg
        • Investigador principal:
          • Andi Eie Albertsen, MD
    • Region Midt
      • Aarhus, Region Midt, Dinamarca, 8200
        • Reclutamiento
        • Aarhus University Hospital (AUH)
        • Investigador principal:
          • Jens Erik Nielsen-Kudsk, MD
    • Region Syddanmark
      • Esbjerg, Region Syddanmark, Dinamarca, 6700
        • Reclutamiento
        • Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark
        • Investigador principal:
          • Axel Brandes, MD
      • Alicante, España, 03010
        • Reclutamiento
        • University General Hospital Dr. Balmis
        • Investigador principal:
          • Juan Miguel Ruiz Nodar, MD
      • Barcelona, España, 08035
        • Reclutamiento
        • Hospital Universitari Vall d'Hebron
        • Investigador principal:
          • Jaume Francisco Pascual, MD
      • Huelva, España, 21005
        • Reclutamiento
        • Hospital Universitario Juan Ramón Jiménez
        • Investigador principal:
          • Antonio Enrique Gómez Menchero, MD
      • León, España, 24071
        • Reclutamiento
        • Complejo Asistencial Universitario de León
        • Investigador principal:
          • Armando Perez de Prado, MD
      • Madrid, España, 28003
        • Reclutamiento
        • Universitario La Luz - Grupo Quirónsalud
        • Investigador principal:
          • Jorge Palazuelos, MD
      • Valladolid, España, 47003
        • Reclutamiento
        • Hospital Clínico Universitario de Valladolid
        • Investigador principal:
          • Ignacio Amat Santos, MD
    • Pontevedra
      • Vigo, Pontevedra, España, 36312
        • Reclutamiento
        • Hospital Álvaro Cunqueiro
        • Investigador principal:
          • Rodrigo Estevez Loureiro, MD
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35243
        • Retirado
        • Affinity Hospital dba Grandview Medical Center
    • Arkansas
      • Jonesboro, Arkansas, Estados Unidos, 72401
        • Reclutamiento
        • Arrhythmia Research Group
        • Investigador principal:
          • Devi Nair, MD
    • California
      • Fountain Valley, California, Estados Unidos, 92708
        • Reclutamiento
        • Memorial Health Services
        • Investigador principal:
          • Nikhil Warrier, MD
      • Loma Linda, California, Estados Unidos, 92354
        • Retirado
        • Loma Linda University Health
      • Los Angeles, California, Estados Unidos, 90048
        • Reclutamiento
        • Cedars-Sinai Medical Center
        • Investigador principal:
          • Tarun Chakravarty, MD
      • Pasadena, California, Estados Unidos, 91101
        • Reclutamiento
        • Southern California Permanente Medical Group
        • Investigador principal:
          • Bahram Khadivi, MD
      • Sacramento, California, Estados Unidos, 95816
        • Reclutamiento
        • Sutter Valley Hospitals dba Sutter Institute for Medical Research
        • Investigador principal:
          • David Roberts, MD
    • Delaware
      • Wilmington, Delaware, Estados Unidos, 19803
        • Reclutamiento
        • Christiana Care Health Services, Inc.
        • Investigador principal:
          • Neil Wimmer, MD
    • Florida
      • Atlantis, Florida, Estados Unidos, 33462
        • Retirado
        • JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital
      • Jacksonville, Florida, Estados Unidos, 32204
        • Retirado
        • St. Vincent's Health System
      • Largo, Florida, Estados Unidos, 33770
        • Retirado
        • Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center
      • Ocala, Florida, Estados Unidos, 34471
        • Retirado
        • HCA Florida Ocala Hospital
      • Tampa, Florida, Estados Unidos, 33620
        • Reclutamiento
        • The University of South Florida
        • Investigador principal:
          • Bibhu Mohanty, MD
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Reclutamiento
        • Emory University
        • Investigador principal:
          • David De Lurgio, MD
    • Idaho
      • Boise, Idaho, Estados Unidos, 83712
        • Reclutamiento
        • St Luke's Regional Medical Center, Ltd
        • Investigador principal:
          • Marcos Daccarett, MD
      • Coeur d'Alene, Idaho, Estados Unidos, 83814
        • Reclutamiento
        • Kootenai Health Inc.
        • Investigador principal:
          • Michele Murphy-Cook, MD
    • Illinois
      • Evanston, Illinois, Estados Unidos, 60208
        • Reclutamiento
        • Northwestern University
        • Investigador principal:
          • Albert Lin, MD
      • Rock Island, Illinois, Estados Unidos, 61201
        • Reclutamiento
        • Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island
        • Investigador principal:
          • Mark Shen, MD
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46256
        • Reclutamiento
        • Community Health Network Inc.
        • Investigador principal:
          • Krishna Malineni, MD
    • Iowa
      • West Des Moines, Iowa, Estados Unidos, 50266
        • Reclutamiento
        • MercyOne Iowa Heart Center
        • Investigador principal:
          • Pitayadet Jumrussirikul, MD
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Reclutamiento
        • University of Kansas Medical Center Research Institute, Inc.
        • Investigador principal:
          • Madhu Reddy, MD
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40503
        • Reclutamiento
        • Babtist Health Lexington
        • Investigador principal:
          • Gery Tomassoni, MD
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70121
        • Reclutamiento
        • Ochsner Clinic Foundation
        • Investigador principal:
          • Richard Zweifler, MD
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • Reclutamiento
        • University of Maryland Baltimore
        • Investigador principal:
          • Seemant Chaturvedi, MD
    • Massachusetts
      • Burlington, Massachusetts, Estados Unidos, 01805
        • Reclutamiento
        • Lahey Clinic Inc.
        • Investigador principal:
          • Bruce Hook, MD
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • Reclutamiento
        • University of Michigan
        • Investigador principal:
          • Hakan Oral, MD
      • Detroit, Michigan, Estados Unidos, 48202
        • Reclutamiento
        • Henry Ford Health System
        • Investigador principal:
          • Amir Kaki, MD
        • Investigador principal:
          • Waddah Maskoun, MD
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Reclutamiento
        • Mayo Clinic
        • Investigador principal:
          • Eugene L. Scharf, MD
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63103
        • Reclutamiento
        • St. Louis University,
        • Investigador principal:
          • Div Verma, MD
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Reclutamiento
        • Hackensack University Medical Center
        • Investigador principal:
          • Taya Glotzer, MD
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87106
        • Reclutamiento
        • Presbyterian Healthcare Services d.b.a. Presbyterian Heart Group
        • Investigador principal:
          • Sharif Halim, MD
    • New York
      • Manhasset, New York, Estados Unidos, 11030
        • Retirado
        • The Feinstein Institutes for Medical Research
      • New York, New York, Estados Unidos, 10065
        • Reclutamiento
        • Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian Hospital
        • Investigador principal:
          • Christopher Liu, MD
      • New York, New York, Estados Unidos, 10065
        • Retirado
        • NYU Grossman School of Medicine
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28801
        • Reclutamiento
        • Mission Hospital HCA
        • Investigador principal:
          • John Rhyner, MD
    • Ohio
      • Canton, Ohio, Estados Unidos, 44710
        • Reclutamiento
        • Aultman Hospital
        • Investigador principal:
          • Firas Hamdan, MD
      • Cincinnati, Ohio, Estados Unidos, 45221
        • Reclutamiento
        • University of Cincinnati
        • Investigador principal:
          • Srinivas Rajsheker, MD
      • Cincinnati, Ohio, Estados Unidos, 45202
        • Reclutamiento
        • TriHealth Inc.
        • Investigador principal:
          • Gaurang Gandhi, MD
      • Cleveland, Ohio, Estados Unidos, 44195
        • Reclutamiento
        • Cleveland Clinic
        • Investigador principal:
          • Oussama Wazni, MD
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74136
        • Reclutamiento
        • Saint Francis Hospital
        • Investigador principal:
          • Tom Hu, MD
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Reclutamiento
        • The Pennsylvania State University and The Milton S. Hershey Medical Center
        • Investigador principal:
          • Soraya Samii, MD
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Reclutamiento
        • The Trustees of the University of Pennsylvania
        • Investigador principal:
          • Steven Messe, MD
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Reclutamiento
        • University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular Institute
        • Investigador principal:
          • Sandeep Jain, MD
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Reclutamiento
        • Rhode Island Hospital
        • Investigador principal:
          • Ana-Lucia Garcia-Guarniz, MD
    • Tennessee
      • Brentwood, Tennessee, Estados Unidos, 37027
        • Retirado
        • Glanecare, Inc. d/b/a HCA Florida Brandon Hospital
      • Memphis, Tennessee, Estados Unidos, 38163
        • Reclutamiento
        • The University of Tennessee
        • Investigador principal:
          • Balaji Krishnaiah, MD
    • Texas
      • Austin, Texas, Estados Unidos, 78705
        • Retirado
        • Texas Cardiac Arrhythmia Research Foundation
      • Dallas, Texas, Estados Unidos, 75204
        • Reclutamiento
        • Baylor Research Institute
        • Investigador principal:
          • Praveen Rao, MD
      • The Woodlands, Texas, Estados Unidos, 77380
        • Retirado
        • Heart Rhythm Associates
      • Tyler, Texas, Estados Unidos, 75701-2263
        • Reclutamiento
        • CHRISTUS Northeast Texas Health System
        • Investigador principal:
          • Stanislav Weiner, MD
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Reclutamiento
        • The Rector and Visitors of the University of Virginia
        • Investigador principal:
          • Rohit Malhotra, MD
    • Washington
      • Tacoma, Washington, Estados Unidos, 98405
        • Reclutamiento
        • CommonSpirit Health Research Institute
        • Investigador principal:
          • Nasir Shariff, MD
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Reclutamiento
        • The Medical College of Wisconsin
        • Investigador principal:
          • James Oujiri, MD
      • Lyon, Francia, 69677
        • Reclutamiento
        • Hospices Civils de Lyon
        • Investigador principal:
          • Brahim Harbaoui, Prof., MD
      • Paris, Francia, 75013
        • Reclutamiento
        • Hôpital Pitie Salpétrière
        • Investigador principal:
          • Johanne Silvain, Prof., MD
      • Paris, Francia, 75018
        • Reclutamiento
        • Hôpital Bichat
        • Investigador principal:
          • Gregory Ducrocq, Prof., MD
      • Paris, Francia, 75908
        • Reclutamiento
        • European Georges Pompidou Hospital
        • Investigador principal:
          • Eloi Marijon, MD
      • Paris, Francia, 75014
        • Reclutamiento
        • Institut Médico-chirurgical Montsouris
        • Investigador principal:
          • Alaa Masri, MD
      • Paris, Francia, 75012
        • Reclutamiento
        • The Fondation de l'AP-HP
        • Investigador principal:
          • Emmanuel Teiger, Prof., MD
    • Essonne
      • Massy, Essonne, Francia, 91300
        • Reclutamiento
        • Hospital Prive Jacques Cartier
        • Investigador principal:
          • Phillipe Garot, MD
    • Indre-et-Loire
      • Tours, Indre-et-Loire, Francia, 37044
        • Reclutamiento
        • Centre Hospitalier Régional Universitaire de Tours
        • Investigador principal:
          • Jean Michel Clerc, MD
    • Isère
      • La Tronche, Isère, Francia, 38700
        • Reclutamiento
        • Centre Hospitalier Universitaire Grenoble-Alps
        • Investigador principal:
          • Pascal Defaye, Prof., MD
    • Moselle
      • Ars-Laquenexy, Moselle, Francia
        • Reclutamiento
        • CHR Metz-Thionville / Hôpital de MERCY
        • Investigador principal:
          • Marwan Yassine, MD
    • Occitanie
      • Toulouse, Occitanie, Francia, 31076
        • Reclutamiento
        • Clinique Pasteur
        • Investigador principal:
          • Serge Boveda, MD
      • Toulouse, Occitanie, Francia, 31076
        • Reclutamiento
        • SCP des Médecins Cardiologues
        • Investigador principal:
          • Bruno Farah, MD
      • Toulouse, Occitanie, Francia, 31059
        • Reclutamiento
        • Centre Hospitalier Universitaire de Toulouse
        • Investigador principal:
          • Meyer Elbaz, Prof., MD
    • Pays de la Loire Region
      • Saint-Étienne-de-Montluc, Pays de la Loire Region, Francia, 42055
        • Reclutamiento
        • CHU Saint Etienne
        • Investigador principal:
          • Antoine Da Costa, Prof., MD
    • Rhône
      • Caluire-et-Cuire, Rhône, Francia, 69300
        • Reclutamiento
        • Infirmerie Protestante de Lyon
        • Investigador principal:
          • Cyril Durand, MD
      • Marseille, Rhône, Francia, 13005
        • Reclutamiento
        • L'Assistance Publique-Hôpitaux de Marseille
        • Investigador principal:
          • Thomas Cuisset, MD
      • Marseille, Rhône, Francia, 13009
        • Reclutamiento
        • Hôpital Privé Clairval
        • Investigador principal:
          • Alexis Mechulan, MD
    • Seine-Saint-Denis
      • Saint-Denis, Seine-Saint-Denis, Francia, 93200
        • Reclutamiento
        • Centre Cardiologique due Nord
        • Investigador principal:
          • Antoine Lepillier, MD
      • Brescia, Italia, 25124
        • Reclutamiento
        • Fondazione Poliambulanza Istituto Ospedaliero
        • Investigador principal:
          • Diego Maffeo, MD
      • Sassari, Italia, 07100
        • Reclutamiento
        • Azienda Ospedaliero Universitaria Sassari
        • Investigador principal:
          • Gavino Casu, Prof., MD
    • North Brabant
      • Eindhoven, North Brabant, Países Bajos, 5623EJ
        • Reclutamiento
        • Stichting Catharina Ziekenhuis
        • Investigador principal:
          • Pepijn van der Voort, MD
    • Utrecht
      • Nieuwegein, Utrecht, Países Bajos, 3435CM
        • Reclutamiento
        • St. Antonius Hospital
        • Investigador principal:
          • Lucas Boersma, Prof., MD
      • Ustroń, Polonia, 43-450
        • Reclutamiento
        • American Heart of Poland SA
        • Investigador principal:
          • Krzysztof Milewski, MD
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polonia, 04-628
        • Reclutamiento
        • Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego
        • Investigador principal:
          • Jerzy Pregowski, MD
      • Liverpool, Reino Unido, L14 3PE
        • Reclutamiento
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
        • Investigador principal:
          • Dhiraj Gupta, MD
      • Southampton, Reino Unido, SO16 6YD
        • Reclutamiento
        • University Hospital Southampton NHS Foundation Trust
        • Investigador principal:
          • John Paisey, MD
    • Leicestershire
      • Leicester, Leicestershire, Reino Unido, LE1 5WW
        • Reclutamiento
        • University Hospitals of Leicester NHS Trust
        • Investigador principal:
          • Jan Kovac, Prof., MD
    • Nottinghamshire
      • Nottingham, Nottinghamshire, Reino Unido, NG5 1PB
        • Reclutamiento
        • Nottingham University Hospital NHS Trust
        • Investigador principal:
          • Ashan Gunarathne, MD
    • Oxfordshire
      • Oxford, Oxfordshire, Reino Unido, OX3 9DU
        • Reclutamiento
        • Oxford University Hospitals NHS Foundation Trust
        • Investigador principal:
          • Tim Betts, MD
    • West Midlands
      • Coventry, West Midlands, Reino Unido, CV2 2DX
        • Reclutamiento
        • University Hospitals Coventry and Warwickshire
        • Investigador principal:
          • Sandeep Panikker, MD
    • West Sussex
      • Worthing, West Sussex, Reino Unido, BN11 2DH
        • Reclutamiento
        • University Hospitals Sussex NHS Trust
        • Investigador principal:
          • David Hildick-Smith, MD
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Suiza, 4031
        • Reclutamiento
        • Universitätsspital Basel
        • Investigador principal:
          • Christian Sticherling, Prof., MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
  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:

  1. Age < 18 years
  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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: WATCHMAN device

Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device

Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device

Sin intervención: Standard Care

Participants will receive local, standard medical care

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ischemic stroke or systemic embolism
Periodo de tiempo: The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

The primary efficacy variable is the time from randomization to first occurrence of any of the components of the composite outcome (adjudicated) over the duration of follow-up, including:

  • Ischemic stroke (Strokes of undetermined etiology will be treated as ischemic stroke)
  • Systemic embolism
The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
All-cause stroke or systemic embolism
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Secondary efficacy outcomes will be evaluated in a hierarchical fashion only when the primary outcome meets statistical significance in the specified order:

Time from randomization to first occurrence of all-cause stroke or systemic embolism

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
All-cause stroke, systemic embolism, or transient ischemic attack (TIA)
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Time from randomization to first occurrence of all-cause stroke, systemic embolism or transient ischemic attack (TIA)

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Montreal Cognitive Assessment (MoCA) Score
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Proportion of participants with a decrease of two or more points on the MoCA score at either year 2 or end of study

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
New disabling ischemic strokes
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Time from randomization to first occurrence of disabling ischemic strokes with modified Rankin Score (mRS) >2, measured at 90 days post-stroke

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Cardiovascular mortality
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Time from randomization to cardiovascular mortality

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
All-cause mortality
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Time from randomization to all-cause mortality

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Non-procedural Major Bleeding
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Proportion of participants with non-procedural Major Bleeding (International Society on Thrombosis and Haemostasis (ISTH) definition; excluding WATCHMAN-related bleeding within 14 days of implant)

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Hospitalization for any cause
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Time from randomization to first occurrence of hospitalization for any cause

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Heart failure hospitalization or emergency department/clinic visit for intensification of heart failure related therapy
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Time from randomization to first occurrence of heart failure hospitalization or emergency department/clinic visit for intensification of heart failure related therapy

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Myocardial Infarction
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Time from randomization to first occurrence of Myocardial Infarction (4th Universal definition)

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Device and procedural-related outcomes: Device-related thrombus
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Proportion of participants with device-related thrombus (thrombus formed on the surface of the WATCHMAN device)

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Device and procedural-related outcomes: Incomplete left atrial appendage (LAA) closure
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Proportion of participants with incomplete LAA closure

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Device and procedural-related outcomes: Peri-procedural major bleeding
Periodo de tiempo: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Proportion of participants with peri-procedural major bleeding (ISTH definition; within 14 days following the procedure)

Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Jeff Healey, Hamilton Health Sciences Corporation

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de noviembre de 2023

Finalización primaria (Estimado)

1 de septiembre de 2029

Finalización del estudio (Estimado)

1 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

5 de julio de 2023

Primero enviado que cumplió con los criterios de control de calidad

18 de julio de 2023

Publicado por primera vez (Actual)

27 de julio de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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