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O Quarto Estudo de Oclusão do Apêndice Atrial Esquerdo (LAAOS-4)

15 de setembro de 2026 atualizado por: Hamilton Health Sciences Corporation

O Quarto Estudo de Oclusão do Apêndice Atrial Esquerdo (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.

Visão geral do estudo

Status

Recrutamento

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

4000

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Program Director
  • Número de telefone: 905-521-2100
  • E-mail: LAAOS-4@phri.ca

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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

Sem intervenção: Standard Care

Participants will receive local, standard medical care

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Ischemic stroke or systemic embolism
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
All-cause stroke or systemic embolism
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Non-procedural Major Bleeding
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Jeff Healey, Hamilton Health Sciences Corporation

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de novembro de 2023

Conclusão Primária (Estimado)

1 de setembro de 2029

Conclusão do estudo (Estimado)

1 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

5 de julho de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de julho de 2023

Primeira postagem (Real)

27 de julho de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de setembro de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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