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Den fjerde venstre atrielle vedhengsokkklusjonsstudien (LAAOS-4)

15. september 2026 oppdatert av: Hamilton Health Sciences Corporation

Den fjerde venstre atrielle vedhengsokkklusjonsstudien (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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Enhet: WATCHMAN device

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

4000

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Program Director
Telefonnummer: 905-521-2100
E-post: LAAOS-4@phri.ca

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

Age < 18 years
Current left atrial appendage thrombus
Prior left atrial appendage occlusion or removal (surgical or percutaneous)
Prior percutaneous atrial septal defect or patent foramen ovale closure
Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation
Planned atrial fibrillation ablation within 90 days of enrollment
Individuals being treated with direct thrombin inhibitors
Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
Anticipated life-expectancy of < 2 years
Patient unable or willing to give informed consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Enkelt

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: WATCHMAN device Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device	Enhet: WATCHMAN device Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Ingen inngripen: Standard Care Participants will receive local, standard medical care

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Ischemic stroke or systemic embolism Tidsramme: 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).

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
All-cause stroke or systemic embolism Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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).

Andre resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Non-procedural Major Bleeding Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hamilton Health Sciences Corporation

Samarbeidspartnere

McMaster University

Boston Scientific Corporation

Population Health Research Institute

Etterforskere

Hovedetterforsker: Jeff Healey, Hamilton Health Sciences Corporation

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Grifoni E, Pagni B, Sansone T, Baldini M, Bertini E, Giannoni S, Di Donato I, Sivieri I, Iandoli G, Mannini M, Giglio E, Vescera V, Brai E, Signorini I, Cosentino E, Micheletti I, Cioni E, Pelagalli G, Dei A, Giordano A, Dainelli F, Romagnoli M, Mattaliano C, Schipani E, Murgida GS, Di Martino S, Francolini V, Masotti L. Clinical Features, Management, and Recurrence of Acute Ischemic Stroke Occurring in Patients on Oral Anticoagulant Treatment for Nonvalvular Atrial Fibrillation: A Real-World Retrospective Study. Neurologist. 2024 Nov 1;29(6):329-338. doi: 10.1097/NRL.0000000000000579.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. november 2023

Primær fullføring (Antatt)

1. september 2029

Studiet fullført (Antatt)

1. desember 2029

Datoer for studieregistrering

Først innsendt

5. juli 2023

Først innsendt som oppfylte QC-kriteriene

18. juli 2023

Først lagt ut (Faktiske)

27. juli 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

LAAOS-4

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Den fjerde venstre atrielle vedhengsokkklusjonsstudien (LAAOS-4)