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NCT05963698NARecruiting

The Fourth Left Atrial Appendage Occlusion Study

Hamilton Health Sciences Corporation

Start Date

11/30/2023

Completion Date

12/1/2029

Summary

LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

Detailed Description

LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

WATCHMAN device

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Atrial FibrillationStroke, IschemicSystemic Embolism

Locations

Affinity Hospital dba Grandview Medical Center

Birmingham, Alabama 35243

United States

Arrhythmia Research Group

Jonesboro, Arkansas 72401

United States

Memorial Health Services

Fountain Valley, California 92708

United States

Loma Linda University Health

Loma Linda, California 92354

United States

Southern California Permanente Medical Group

Pasadena, California 91101

United States

Sutter Valley Hospitals dba Sutter Institute for Medical Research

Sacramento, California 95816

United States

JFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital

Atlantis, Florida 33462

United States

St. Vincent's Health System

Jacksonville, Florida 32204

United States

Largo Medical Center, Inc. d/b/a HCA Florida Largo Medical Center

Largo, Florida 33770

United States

HCA Florida Ocala Hospital

Ocala, Florida 34471

United States

The University of South Florida

Tampa, Florida 33620

United States

Emory University

Atlanta, Georgia 30322

United States

St Luke's Regional Medical Center, Ltd

Boise, Idaho 83712

United States

Kootenai Health Inc.

Coeur d'Alene, Idaho 83814

United States

Northwestern University

Evanston, Illinois 60208

United States

Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island

Rock Island, Illinois 61201

United States

Community Health Network Inc.

Indianapolis, Indiana 46256

United States

MercyOne Iowa Heart Center

West Des Moines, Iowa 50266

United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas 66160

United States

Babtist Health Lexington

Lexington, Kentucky 40503

United States

Ochsner Clinic Foundation

New Orleans, Louisiana 70121

United States

University of Maryland Baltimore

Baltimore, Maryland 21201

United States

Lahey Clinic Inc.

Burlington, Massachusetts 01805

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Presbyterian Healthcare Services d.b.a. Presbyterian Heart Group

Albuquerque, New Mexico 87106

United States

The Feinstein Institutes for Medical Research

Manhasset, New York 11030

United States

Cornell University for and on behalf of its Joan & Sanford I. Weill Medical College and The New York Presbyterian Hospital

New York, New York 10065

United States

NYU Grossman School of Medicine

New York, New York 10065

United States

Mission Hospital HCA

Asheville, North Carolina 28801

United States

Aultman Hospital

Canton, Ohio 44710

United States

TriHealth Inc.

Cincinnati, Ohio 45202

United States

University of Cincinnati

Cincinnati, Ohio 45221

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Saint Francis Hospital

Tulsa, Oklahoma 74136

United States

The Pennsylvania State University and The Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

The Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh Medical Center (UPMC) Presbyterian Heart and Vascular Institute

Pittsburgh, Pennsylvania 15213

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Glanecare, Inc. d/b/a HCA Florida Brandon Hospital

Brentwood, Tennessee 37027

United States

The University of Tennessee

Memphis, Tennessee 38163

United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas 78705

United States

Baylor Research Institute

Dallas, Texas 75204

United States

Heart Rhythm Associates

The Woodlands, Texas 77380

United States

CHRISTUS Northeast Texas Health System

Tyler, Texas 75701-2263

United States

The Rector and Visitors of the University of Virginia

Charlottesville, Virginia 22903

United States

CommonSpirit Health Research Institute

Tacoma, Washington 98405

United States

The Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Imeldaziekenhuis

Bonheiden, Antwerpen 2820

Belgium

AZORG vzw and Hartcentrum Aalst

Aalst, East-Flanders 9300

Belgium

ASBL CHU Helora - Hôpital de La Louvière - site Jolimont

La Louvière, Hainaut 7100

Belgium

CHR de la Citadelle

Liège, Liège 4000

Belgium

AZ Glorieux

Ronse, Oost-Vlaanderen 9600

Belgium

AZ Sint Jan Brugge AV

Bruges, West-Vlaanderen 8000

Belgium

AZ Delta VZW

Roeselare, West-Vlaanderen 8800

Belgium

Universitair Ziekenhuis Brussel

Brussels, 1090

Belgium

University of Calgary

Calgary, Alberta T2N 1N4

Canada

Vancouver Coastal Health Authority

Vancouver, British Columbia V5Z 1M9

Canada

St. Boniface Hospital Inc.

Winnipeg, Manitoba R2H 2A6

Canada

Circulate Cardiac & Vascular Centre (CCVC)

Burlington, Ontario L7M 1K9

Canada

Cambridge Cardiac Care Inc.

Cambridge, Ontario N1R 6V6

Canada

Hamilton Health Sciences Corp

Hamilton, Ontario L8L 2X2

Canada

Research St. Joseph's - Hamilton

Hamilton, Ontario L8N 4A6

Canada

Waterloo Wellington Cardiovascular Research Institute (WWCRI)

Kitchener, Ontario N2M 5N6

Canada

Lawson Health Research Institute

London, Ontario N6A 2R5

Canada

Southlake Regional Health Centre

Newmarket, Ontario L2Y 2P9

Canada

Partners in Advanced Cardiac Evaluation (PACE)

Newmarket, Ontario L3Y 2P6

Canada

Ottawa Heart Institute Research Corp

Ottawa, Ontario K1Y 4W7

Canada

Niagara Health System - Niagara Falls

St. Catharines, Ontario L2S 0A9

Canada

Niagara Health Systems - St. Catharines

St. Catharines, Ontario L2S 0A9

Canada

Sunnybrook Health Sciences Center

Toronto, Ontario M4N 3M5

Canada

Lawrence Park Cardiology

Toronto, Ontario M4N 3N1

Canada

Unity Health Toronto

Toronto, Ontario M5B 1W8

Canada

University Health Network

Toronto, Ontario M5G 2C4

Canada

Institut de Cardiologie de Montreal (ICM)

Montreal, Quebec H1T 1C8

Canada

Centre hospitalier de l'Université de Montréal

Montreal, Quebec H2X OC1

Canada

Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

Québec, Quebec G1V 4G5

Canada

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)

Sherbrooke, Quebec J1J 3H5

Canada

Prairie Valscular Research Inc. (PVRI)

Regina, Saskatchewan S4P 0W5

Canada

Saskatchewan Health Authority

Saskatoon, Saskatchewan S7K 0M7

Canada

Region Hospital Viborg

Viborg, Central Jutland 8800

Denmark

Aarhus University Hospital (AUH)

Aarhus, Region Midt 8200

Denmark

Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark

Esbjerg, Region Syddanmark 6700

Denmark

Rigshospitalet (RH)

Copenhagen, 2100

Denmark

North Denmark Regional Hospital

Hjørring, 9800

Denmark

Odense Universitets Hospital

Odense C, 4500

Denmark

Infirmerie Protestante de Lyon

Caluire-et-Cuire, Auvergne-Rhône-Alpes 69300

France

CHU Saint Etienne

Saint-Etienne, Auvergne-Rhône-Alpes 42055

France

Centre Hospitalier Régional Universitaire de Tours

Tours, Centre-Val de Loire 37044

France

CHR Metz-Thionville / Hôpital de MERCY

Ars-Laquenexy, Moselle

France

Centre Hospitalier Universitaire de Toulouse

Toulouse, Occitanie 31059

France

Clinique Pasteur

Toulouse, Occitanie 31076

France

SCP des Médecins Cardiologues

Toulouse, Occitanie 31076

France

The Fondation de l'AP-HP

Paris, Paris 75012

France

L'Assistance Publique-Hôpitaux de Marseille

Marseille, Provence-Alpes-Côte d'Azur Region 13005

France

Hôpital Pitie Salpétrière

Paris, 75013

France

Institut Médico-chirurgical Montsouris

Paris, 75014

France

Hôpital Bichat

Paris, 75018

France

European Georges Pompidou Hospital

Paris, 75908

France

Hospital Prive Jacques Cartier

Massy, Île-de-France Region 91300

France

Centre Cardiologique due Nord

Saint-Denis, Île-de-France Region 93200

France

Städtisches Klinikum Karsruhe gGmbH

Karlsruhe, Baden-Wurttemberg 76133

Germany

Kardiovaskulaeres Zentrum Darmstadt

Darmstadt, Hesse 64287

Germany

CVC Rhein-Main GmbH

Frankfurt am Main, Hesse 60389

Germany

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt am Main, Hesse 60431

Germany

Johann Wolfgang Goethe Universität Franfurt - Universitätsklinikum Franfurt

Frankfurt am Main, Hesse 60590

Germany

Universitätsmedizin Rostock

Rostock, Mecklenburg-Vorpommern D-18057

Germany

Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH

Bad Oeynhausen, North Rhine-Westphalia 32545

Germany

Westpfalz-Klinikum GmbH

Kaiserslautern, Rhineland-Palatinate 67665

Germany

Herzzentrum Leipzig GmbH

Leipzig, Saxony 04289

Germany

Heinrich-Braun-Klinikum gemeinnützige GmbH

Zwickau, Saxony 08060

Germany

Universitätsklinikum Schleswig - Holstein

Lübeck, Schleswig-Holstein 23538

Germany

Katholisches Krankenhaus "St. Johann Nepomuk"

Erfurt, Thuringia 99097

Germany

Charité Universitätsmedizin Berlin

Berlin, 10117

Germany

Charité - Universitätsmedizin Berlin

Berlin, 12203

Germany

Asklepios Kliniken Hamburg GmbH

Hamburg, 20099

Germany

Asklepios Kliniken Hamburg GmbH

Hamburg, 20099

Germany

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, 20246

Germany

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

Azienda Ospedaliero Universitaria Sassari

Sassari, Sassari 07100

Italy

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124

Italy

Stichting Catharina Ziekenhuis

Eindhoven, North Brabant 5623EJ

Netherlands

Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego

Warsaw, Masovian Voivodeship 04-628

Poland

American Heart of Poland SA

Ustroń, 43-450

Poland

Hospital Álvaro Cunqueiro

Vigo, Pontevedra 36312

Spain

University General Hospital Dr. Balmis

Alicante, 03010

Spain

Complejo Asistencial Universitario de León

León, 24071

Spain

Universitario La Luz - Grupo Quirónsalud

Madrid, 28003

Spain

Hospital Clínico Universitario de Valladolid

Valladolid, 47003

Spain

Universitätsspital Basel

Basel, Canton of Basel-City 4031

Switzerland

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire LE1 5WW

United Kingdom

Nottingham University Hospital NHS Trust

Nottingham, Nottinghamshire NG5 1PB

United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire OX3 9DU

United Kingdom

University Hospitals Coventry and Warwickshire

Coventry, West Midlands CV2 2DX

United Kingdom

University Hospitals Sussex NHS Trust

Worthing, West Sussex BN11 2DH

United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, L14 3PE

United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD

United Kingdom