RecruitingNot ApplicableNCT05963698

The Fourth Left Atrial Appendage Occlusion Study

The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4)


Sponsor

Hamilton Health Sciences Corporation

Enrollment

4,000 participants

Start Date

Nov 30, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether left atrial appendage occlusion (LAAO) — a procedure to close off the part of the heart where most stroke-causing clots form in AF — reduces strokes and bleeding compared to staying on blood thinners. **You may be eligible if...** - You have persistent, permanent, or paroxysmal atrial fibrillation with a prior stroke or embolism - Your stroke risk score (CHA2DS2-VASc) is 4 or higher - You have been on an oral anticoagulant for at least 90 days and plan to continue during the trial - You are 18 or older **You may NOT be eligible if...** - You currently have a clot in your left atrial appendage - You have had a prior LAAO procedure or had the appendage surgically removed - You have had atrial fibrillation ablation unless AF has since recurred - You have a life expectancy of less than 2 years - You are pregnant or of childbearing potential without effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWATCHMAN device

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


Locations(127)

Affinity Hospital dba Grandview Medical Center

Birmingham, Alabama, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Memorial Health Services

Fountain Valley, California, United States

Loma Linda University Health

Loma Linda, California, United States

Southern California Permanente Medical Group

Pasadena, California, United States

Sutter Valley Hospitals dba Sutter Institute for Medical Research

Sacramento, California, United States

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

Atlantis, Florida, United States

St. Vincent's Health System

Jacksonville, Florida, United States

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

Largo, Florida, United States

The University of South Florida

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

St Luke's Regional Medical Center, Ltd

Boise, Idaho, United States

Kootenai Health Inc.

Coeur d'Alene, Idaho, United States

Northwestern University

Evanston, Illinois, United States

Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island

Rock Island, Illinois, United States

Community Health Network Inc.

Indianapolis, Indiana, United States

MercyOne Iowa Heart Center

West Des Moines, Iowa, United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, United States

Babtist Health Lexington

Lexington, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

University of Maryland Baltimore

Baltimore, Maryland, United States

Lahey Clinic Inc.

Burlington, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

The Feinstein Institutes for Medical Research

Manhasset, New York, 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, United States

NYU Grossman School of Medicine

New York, New York, United States

Mission Hospital HCA

Asheville, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

TriHealth Inc.

Cincinnati, Ohio, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Saint Francis Hospital

Tulsa, Oklahoma, United States

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

Hershey, Pennsylvania, United States

The Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

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

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

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

Brentwood, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Baylor Research Institute

Dallas, Texas, United States

Heart Rhythm Associates

The Woodlands, Texas, United States

CHRISTUS Northeast Texas Health System

Tyler, Texas, United States

The Rector and Visitors of the University of Virginia

Charlottesville, Virginia, United States

CommonSpirit Health Research Institute

Tacoma, Washington, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Imeldaziekenhuis

Bonheiden, Antwerpen, Belgium

AZORG vzw and Hartcentrum Aalst

Aalst, East-Flanders, Belgium

ASBL CHU Helora - Hôpital de La Louvière - site Jolimont

La Louvière, Hainaut, Belgium

CHR de la Citadelle

Liège, Liège, Belgium

AZ Glorieux

Ronse, Oost-Vlaanderen, Belgium

AZ Sint Jan Brugge AV

Bruges, West-Vlaanderen, Belgium

AZ Delta VZW

Roeselare, West-Vlaanderen, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

University of Calgary

Calgary, Alberta, Canada

Vancouver Coastal Health Authority

Vancouver, British Columbia, Canada

St. Boniface Hospital Inc.

Winnipeg, Manitoba, Canada

Circulate Cardiac & Vascular Centre (CCVC)

Burlington, Ontario, Canada

Cambridge Cardiac Care Inc.

Cambridge, Ontario, Canada

Hamilton Health Sciences Corp

Hamilton, Ontario, Canada

Research St. Joseph's - Hamilton

Hamilton, Ontario, Canada

Waterloo Wellington Cardiovascular Research Institute (WWCRI)

Kitchener, Ontario, Canada

Lawson Health Research Institute

London, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Partners in Advanced Cardiac Evaluation (PACE)

Newmarket, Ontario, Canada

Ottawa Heart Institute Research Corp

Ottawa, Ontario, Canada

Niagara Health System - Niagara Falls

St. Catharines, Ontario, Canada

Niagara Health Systems - St. Catharines

St. Catharines, Ontario, Canada

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Lawrence Park Cardiology

Toronto, Ontario, Canada

Unity Health Toronto

Toronto, Ontario, Canada

Institut de Cardiologie de Montreal (ICM)

Montreal, Quebec, Canada

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

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

Québec, Quebec, 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, Canada

Prairie Valscular Research Inc. (PVRI)

Regina, Saskatchewan, Canada

Saskatchewan Health Authority

Saskatoon, Saskatchewan, Canada

Region Hospital Viborg

Viborg, Central Jutland, Denmark

Aarhus University Hospital (AUH)

Aarhus, Region Midt, Denmark

Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark

Esbjerg, Region Syddanmark, Denmark

Rigshospitalet (RH)

Copenhagen, Denmark

North Denmark Regional Hospital

Hjørring, Denmark

Odense Universitets Hospital

Odense C, Denmark

Infirmerie Protestante de Lyon

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

CHU Saint Etienne

Saint-Etienne, Auvergne-Rhône-Alpes, France

Centre Hospitalier Régional Universitaire de Tours

Tours, Centre-Val de Loire, France

Clinique Pasteur

Toulouse, Occitanie, France

SCP des Médecins Cardiologues

Toulouse, Occitanie, France

L'Assistance Publique-Hôpitaux de Marseille

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

Hôpital Pitie Salpétrière

Paris, France

Institut Médico-chirurgical Montsouris

Paris, France

Hôpital Bichat

Paris, France

European Georges Pompidou Hospital

Paris, France

Hospital Prive Jacques Cartier

Massy, Île-de-France Region, France

Centre Cardiologique due Nord

Saint-Denis, Île-de-France Region, France

Städtisches Klinikum Karsruhe gGmbH

Karlsruhe, Baden-Wurttemberg, Germany

Kardiovaskulaeres Zentrum Darmstadt

Darmstadt, Hesse, Germany

CVC Rhein-Main GmbH

Frankfurt am Main, Hesse, Germany

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt am Main, Hesse, Germany

Johann Wolfgang Goethe Universität Franfurt - Universitätsklinikum Franfurt

Frankfurt am Main, Hesse, Germany

Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH

Bad Oeynhausen, North Rhine-Westphalia, Germany

Westpfalz-Klinikum GmbH

Kaiserslautern, Rhineland-Palatinate, Germany

Herzzentrum Leipzig GmbH

Leipzig, Saxony, Germany

Universitätsklinikum Schleswig - Holstein

Lübeck, Schleswig-Holstein, Germany

Katholisches Krankenhaus "St. Johann Nepomuk"

Erfurt, Thuringia, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Asklepios Kliniken Hamburg GmbH

Hamburg, Germany

Asklepios Kliniken Hamburg GmbH

Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, Italy

Stichting Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

American Heart of Poland SA

Ustroń, Poland

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

University General Hospital Dr. Balmis

Alicante, Spain

Complejo Asistencial Universitario de León

León, Spain

Universitario La Luz - Grupo Quirónsalud

Madrid, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

University Hospitals Coventry and Warwickshire

Coventry, West Midlands, United Kingdom

University Hospitals Sussex NHS Trust

Worthing, West Sussex, United Kingdom

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05963698


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