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New device aims to stop strokes in High-Risk heart patients

NCT ID NCT05963698

Disease control Sponsor: Hamilton Health Sciences Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

This study tests if a catheter-based device that closes a small pouch in the heart (left atrial appendage) can prevent strokes or blood clots in people with atrial fibrillation who are already taking blood thinners. About 4000 participants at high risk of stroke will be enrolled. The goal is to see if adding this procedure to standard medication offers extra protection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation ischemic stroke prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Stroke, ischemic Systemic embolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    138 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASBL CHU Helora - Hôpital de La Louvière - site Jolimont

    RECRUITING

    La Louvière, Hainaut, 7100, Belgium

  • AZ Delta VZW

    RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • AZ Glorieux

    RECRUITING

    Ronse, Oost-Vlaanderen, 9600, Belgium

  • AZ Sint Jan Brugge AV

    RECRUITING

    Bruges, West-Vlaanderen, 8000, Belgium

  • AZORG vzw and Hartcentrum Aalst

    RECRUITING

    Aalst, East-Flanders, 9300, Belgium

  • Aarhus University Hospital (AUH)

    RECRUITING

    Aarhus, Region Midt, 8200, Denmark

  • Affinity Hospital dba Grandview Medical Center

    WITHDRAWN

    Birmingham, Alabama, 35243, United States

  • American Heart of Poland SA

    RECRUITING

    Ustroń, 43-450, Poland

  • Arrhythmia Research Group

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Asklepios Kliniken Hamburg GmbH

    RECRUITING

    Hamburg, 20099, Germany

  • Asklepios Kliniken Hamburg GmbH

    RECRUITING

    Hamburg, 20099, Germany

  • Aultman Hospital

    RECRUITING

    Canton, Ohio, 44710, United States

  • Azienda Ospedaliero Universitaria Sassari

    RECRUITING

    Sassari, 07100, Italy

  • Babtist Health Lexington

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Baylor Research Institute

    RECRUITING

    Dallas, Texas, 75204, United States

  • CHR Metz-Thionville / Hôpital de MERCY

    RECRUITING

    Ars-Laquenexy, Moselle, France

  • CHR de la Citadelle

    RECRUITING

    Liège, 4000, Belgium

  • CHRISTUS Northeast Texas Health System

    RECRUITING

    Tyler, Texas, 75701-2263, United States

  • CHU Saint Etienne

    RECRUITING

    Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France

  • CVC Rhein-Main GmbH

    RECRUITING

    Frankfurt am Main, Hesse, 60389, Germany

  • Cambridge Cardiac Care Inc.

    RECRUITING

    Cambridge, Ontario, N1R 6V6, Canada

  • Cardiovascular Medicine, PLLC and Unity Point Trinity Rock Island

    RECRUITING

    Rock Island, Illinois, 61201, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centre Cardiologique due Nord

    RECRUITING

    Saint-Denis, Seine-Saint-Denis, 93200, France

  • Centre Hospitalier Régional Universitaire de Tours

    RECRUITING

    Tours, Indre-et-Loire, 37044, France

  • Centre Hospitalier Universitaire Grenoble-Alps

    RECRUITING

    La Tronche, Isère, 38700, France

  • Centre Hospitalier Universitaire de Toulouse

    RECRUITING

    Toulouse, Occitanie, 31059, France

  • Centre hospitalier de l'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2X OC1, Canada

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

    RECRUITING

    Sherbrooke, Quebec, J1J 3H5, Canada

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 12203, Germany

  • Charité Universitätsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Christiana Care Health Services, Inc.

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Circulate Cardiac & Vascular Centre (CCVC)

    RECRUITING

    Burlington, Ontario, L7M 1K9, Canada

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinique Pasteur

    RECRUITING

    Toulouse, Occitanie, 31076, France

  • CommonSpirit Health Research Institute

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Community Health Network Inc.

    RECRUITING

    Indianapolis, Indiana, 46256, United States

  • Complejo Asistencial Universitario de León

    RECRUITING

    León, 24071, Spain

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

    RECRUITING

    New York, New York, 10065, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark

    RECRUITING

    Esbjerg, Region Syddanmark, 6700, Denmark

  • European Georges Pompidou Hospital

    RECRUITING

    Paris, 75908, France

  • Fondazione Poliambulanza Istituto Ospedaliero

    RECRUITING

    Brescia, 25124, Italy

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

    WITHDRAWN

    Brentwood, Tennessee, 37027, United States

  • HCA Florida Ocala Hospital

    WITHDRAWN

    Ocala, Florida, 34471, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hamilton Health Sciences Corp

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Heart Rhythm Associates

    WITHDRAWN

    The Woodlands, Texas, 77380, United States

  • Heinrich-Braun-Klinikum gemeinnützige GmbH

    RECRUITING

    Zwickau, Saxony, 08060, Germany

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Herzzentrum Leipzig GmbH

    RECRUITING

    Leipzig, Saxony, 04289, Germany

  • Hospices Civils de Lyon

    RECRUITING

    Lyon, 69677, France

  • Hospital Clínico Universitario de Valladolid

    RECRUITING

    Valladolid, 47003, Spain

  • Hospital Prive Jacques Cartier

    RECRUITING

    Massy, Essonne, 91300, France

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Juan Ramón Jiménez

    RECRUITING

    Huelva, 21005, Spain

  • Hospital Álvaro Cunqueiro

    RECRUITING

    Vigo, Pontevedra, 36312, Spain

  • Hôpital Bichat

    RECRUITING

    Paris, 75018, France

  • Hôpital Pitie Salpétrière

    RECRUITING

    Paris, 75013, France

  • Hôpital Privé Clairval

    RECRUITING

    Marseille, Rhône, 13009, France

  • Imeldaziekenhuis

    RECRUITING

    Bonheiden, Antwerpen, 2820, Belgium

  • Infirmerie Protestante de Lyon

    RECRUITING

    Caluire-et-Cuire, Rhône, 69300, France

  • Institut Médico-chirurgical Montsouris

    RECRUITING

    Paris, 75014, France

  • Institut de Cardiologie de Montreal (ICM)

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

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

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

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

    WITHDRAWN

    Atlantis, Florida, 33462, United States

  • Johann Wolfgang Goethe Universität Franfurt - Universitätsklinikum Franfurt

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • Kardiovaskulaeres Zentrum Darmstadt

    RECRUITING

    Darmstadt, Hesse, 64287, Germany

  • Katholisches Krankenhaus "St. Johann Nepomuk"

    RECRUITING

    Erfurt, Thuringia, 99097, Germany

  • Kootenai Health Inc.

    RECRUITING

    Coeur d'Alene, Idaho, 83814, United States

  • Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH

    RECRUITING

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • L'Assistance Publique-Hôpitaux de Marseille

    RECRUITING

    Marseille, Rhône, 13005, France

  • Lahey Clinic Inc.

    RECRUITING

    Burlington, Massachusetts, 01805, United States

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

    WITHDRAWN

    Largo, Florida, 33770, United States

  • Lawrence Park Cardiology

    RECRUITING

    Toronto, Ontario, M4N 3N1, Canada

  • Lawson Health Research Institute

    RECRUITING

    London, Ontario, N6A 2R5, Canada

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    RECRUITING

    Liverpool, L14 3PE, United Kingdom

  • Loma Linda University Health

    WITHDRAWN

    Loma Linda, California, 92354, United States

  • MVZ CCB Frankfurt und Main-Taunus GbR

    RECRUITING

    Frankfurt am Main, Hesse, 60431, Germany

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Health Services

    RECRUITING

    Fountain Valley, California, 92708, United States

  • MercyOne Iowa Heart Center

    RECRUITING

    West Des Moines, Iowa, 50266, United States

  • Mission Hospital HCA

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • NYU Grossman School of Medicine

    WITHDRAWN

    New York, New York, 10065, United States

  • Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego

    RECRUITING

    Warsaw, Masovian Voivodeship, 04-628, Poland

  • Niagara Health System - Niagara Falls

    WITHDRAWN

    St. Catharines, Ontario, L2S 0A9, Canada

  • Niagara Health Systems - St. Catharines

    RECRUITING

    St. Catharines, Ontario, L2S 0A9, Canada

  • North Denmark Regional Hospital

    RECRUITING

    Hjørring, 9800, Denmark

  • Northwestern University

    RECRUITING

    Evanston, Illinois, 60208, United States

  • Nottingham University Hospital NHS Trust

    RECRUITING

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Ochsner Clinic Foundation

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Odense Universitets Hospital

    RECRUITING

    Odense C, 4500, Denmark

  • Ottawa Heart Institute Research Corp

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Partners in Advanced Cardiac Evaluation (PACE)

    RECRUITING

    Newmarket, Ontario, L3Y 2P6, Canada

  • Prairie Valscular Research Inc. (PVRI)

    RECRUITING

    Regina, Saskatchewan, S4P 0W5, Canada

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

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • Region Hospital Viborg

    RECRUITING

    Viborg, Central Jutland, 8800, Denmark

  • Research St. Joseph's - Hamilton

    RECRUITING

    Hamilton, Ontario, L8N 4A6, Canada

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Rigshospitalet (RH)

    RECRUITING

    Copenhagen, 2100, Denmark

  • SCP des Médecins Cardiologues

    RECRUITING

    Toulouse, Occitanie, 31076, France

  • Saint Francis Hospital

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • Saskatchewan Health Authority

    RECRUITING

    Saskatoon, Saskatchewan, S7K 0M7, Canada

  • Southern California Permanente Medical Group

    RECRUITING

    Pasadena, California, 91101, United States

  • Southlake Regional Health Centre

    RECRUITING

    Newmarket, Ontario, L2Y 2P9, Canada

  • St Luke's Regional Medical Center, Ltd

    RECRUITING

    Boise, Idaho, 83712, United States

  • St. Antonius Hospital

    RECRUITING

    Nieuwegein, Utrecht, 3435CM, Netherlands

  • St. Boniface Hospital Inc.

    RECRUITING

    Winnipeg, Manitoba, R2H 2A6, Canada

  • St. Louis University,

    RECRUITING

    St Louis, Missouri, 63103, United States

  • St. Vincent's Health System

    WITHDRAWN

    Jacksonville, Florida, 32204, United States

  • Stichting Catharina Ziekenhuis

    RECRUITING

    Eindhoven, North Brabant, 5623EJ, Netherlands

  • Städtisches Klinikum Karsruhe gGmbH

    RECRUITING

    Karlsruhe, Baden-Wurttemberg, 76133, Germany

  • Sunnybrook Health Sciences Center

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Sutter Valley Hospitals dba Sutter Institute for Medical Research

    RECRUITING

    Sacramento, California, 95816, United States

  • Texas Cardiac Arrhythmia Research Foundation

    WITHDRAWN

    Austin, Texas, 78705, United States

  • The Feinstein Institutes for Medical Research

    WITHDRAWN

    Manhasset, New York, 11030, United States

  • The Fondation de l'AP-HP

    RECRUITING

    Paris, 75012, France

  • The Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

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

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • The Rector and Visitors of the University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • The Trustees of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • The University of South Florida

    RECRUITING

    Tampa, Florida, 33620, United States

  • The University of Tennessee

    RECRUITING

    Memphis, Tennessee, 38163, United States

  • TriHealth Inc.

    RECRUITING

    Cincinnati, Ohio, 45202, United States

  • Unity Health Toronto

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • Universitair Ziekenhuis Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • Universitario La Luz - Grupo Quirónsalud

    RECRUITING

    Madrid, 28003, Spain

  • University General Hospital Dr. Balmis

    RECRUITING

    Alicante, 03010, Spain

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • University Hospitals Coventry and Warwickshire

    RECRUITING

    Coventry, West Midlands, CV2 2DX, United Kingdom

  • University Hospitals Sussex NHS Trust

    RECRUITING

    Worthing, West Sussex, BN11 2DH, United Kingdom

  • University Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 1N4, Canada

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45221, United States

  • University of Kansas Medical Center Research Institute, Inc.

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Maryland Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitätsklinikum Köln (AöR)

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitätsklinikum Schleswig - Holstein

    RECRUITING

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitätsmedizin Rostock

    RECRUITING

    Rostock, Mecklenburg-Vorpommern, D-18057, Germany

  • Universitätsspital Basel

    RECRUITING

    Basel, Canton of Basel-City, 4031, Switzerland

  • Vancouver Coastal Health Authority

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Waterloo Wellington Cardiovascular Research Institute (WWCRI)

    RECRUITING

    Kitchener, Ontario, N2M 5N6, Canada

  • Westpfalz-Klinikum GmbH

    RECRUITING

    Kaiserslautern, Rhineland-Palatinate, 67665, Germany

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