Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
3000 participants
INTERVENTIONAL
2020-10-15
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
NCT03795298
Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
NCT02702271
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
NCT01182441
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
NCT00129545
Concomitant LAAC/AF Ablation (Watchman FLX Pro)
NCT07041125
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Device Group
Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device
WATCHMAN FLX LAAC Device
WATCHMAN FLX LAAC Device Implantation
Control Group
Randomized to non-vitamin K oral anticoagulant (NOAC)
Non-Vitamin K Oral Anticoagulant
Initiation or continuation of a NOAC drug
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
WATCHMAN FLX LAAC Device
WATCHMAN FLX LAAC Device Implantation
Non-Vitamin K Oral Anticoagulant
Initiation or continuation of a NOAC drug
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve)
* The subject has a calculated CHA2DS2-VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) score of 2 or greater for men and 3 or greater for women
* The subject is deemed to be suitable for the protocol-defined pharmacologic regimens in both the test and control arms
* The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial
* The subject is able and willing to return for required follow-up visits and examinations
Exclusion Criteria
* The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoagulable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic OAC therapy)
* The subject is contraindicated or allergic to oral anticoagulation medication and/or aspirin
* The subject is indicated for chronic P2Y12 platelet inhibitor therapy
* The subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to: cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery, etc.)
* The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment
* The subject had a prior major bleeding event per ISTH definition within the 30 days prior to randomization. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event
* The subject has an active bleed
* The subject has a reversible cause of AF or transient AF
* The subject is absent of a left atrial appendage (LAA) or the LAA is surgically ligated
* The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to enrollment
* The subject has a history of atrial septal repair or has an atrial septal device (ASD)/patent foramen ovale (PFO) device
* The subject has an implanted mechanical valve prosthesis in any position
* The subject has a known contraindication to percutaneous catheterization procedure
* The subject has a known contraindication to transesophageal echo (TEE)
* The subject has a cardiac tumor
* The subject has signs/symptoms of acute or chronic pericarditis.
* The subject has an active infection
* There is evidence of tamponade physiology
* The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment
* The subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment upon study physician's discretion)
* The subject has a documented life expectancy of less than 3 years
* The subject has left ventricular ejection fraction ( LVEF) \< 30%
* The subject has an existing pericardial effusion with a circumferential echo-free space \> 5mm
* The subject has a high-risk PFO with an atrial septal aneurysm excursion \> 15mm or length \> 15mm
* The subject has significant mitral valve (MV) stenosis (i.e., MV area \<1.5 cm2)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston Scientific Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marty Leon, MD
Role: STUDY_CHAIR
New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center
Kenneth A Ellenbogen, MD
Role: STUDY_CHAIR
Virginia Commonwealth University
Shephal Doshi, MD
Role: PRINCIPAL_INVESTIGATOR
Pacific Heart Institute and Providence St. John's Health Center
Saibal Kar, MD
Role: PRINCIPAL_INVESTIGATOR
HCA Healthhcare /Los Robles Health System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Grandview Medical Center
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States
Tucson Medical Center Healthcare
Tucson, Arizona, United States
Arrythmia Research Group
Jonesboro, Arkansas, United States
Sharp Chula Vista Medical Center
Chula Vista, California, United States
Marin General Hospital
Greenbrae, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
Los Robles Hospital and Medical Center
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Mercy General Hospital
Sacramento, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
St. John's Health Center
Santa Monica, California, United States
Colorado Springs Cardiologist, P.C.
Colorado Springs, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Community Hospital
Munster, Indiana, United States
Mercy Hospital Medical Center
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Norton Hospital
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lahey Clinic Hospital
Burlington, Massachusetts, United States
Charlton Memorial
Fall River, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Sparrow Health System - Sparrow Hospital
Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Mayo Clinic Foundation
Rochester, Minnesota, United States
Centracare Heart and Vascular Center
Saint Cloud, Minnesota, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Billings Clinic
Billings, Montana, United States
Bergan Cardiology
Omaha, Nebraska, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Kaleida Health
Buffalo, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
OhioHealth Research and Innovation Institute-Riverside Methodist Hospital
Columbus, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Legacy Emanuel Hospital & Health Center
Portland, Oregon, United States
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Trident Medical Center
Charleston, South Carolina, United States
Medical University of South Carolina
Columbia, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Methodist Le Bonheur Healthcare
Germantown, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
Heart Hospital of Austin
Austin, Texas, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Methodist Texsan Hospital
San Antonio, Texas, United States
Christus Trinity Mother Frances Health System
Tyler, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
CHI Franciscan Health System
Tacoma, Washington, United States
PeaceHealth Southwest Medical
Vancouver, Washington, United States
Monongalia General Hospital
Morgantown, West Virginia, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
St. Vincent's Hospital-Sydney
Darlinghurst, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Westmead Hospital
Bella Vista, , Australia
Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
CHU de Charleroi
Charleroi, , Belgium
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec, , Canada
Aarhus University Hospital
Aarhus, , Denmark
Hopital Cardiologique de Lyon
Bron, , France
CHU Grenoble-Hopital Michallon
Grenoble, , France
Hospital de la Pitie-Salpetriere
Paris, , France
Charite, Campus Benjamin Franklin
Berlin, , Germany
SANA Kliniken Oberfranken Coburg GmbH
Coburg, , Germany
Herzzentrum Dresden GmbH
Dresden, , Germany
St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
Erfurt, , Germany
Elisabeth Krankenhaus Essen
Essen, , Germany
St. Katharinen Krankenhaus
Frankfurt, , Germany
Cardiologicum Hamburg Praxis Wandsbek
Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein
Lübeck, , Germany
Klinikum der Ludwig-Maximilians-Universitat
München, , Germany
Shaare Zedek Medical Center
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Fondazione Toscana Gabriele Monasterio
Pisa, PI, Italy
Azienda Ospedaliera Careggi
Florence, , Italy
Ospedale Degli Infermi
Rivoli, , Italy
Instituto Clinico Humanitas
Rozzano, , Italy
Chiba University Hospital
Chiba, Chiba, Japan
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo, Japan
Shonan Kamakura General Hospital
Okamoto, , Japan
Kurashiki Central Hospital
Okayama, , Japan
Toho University Ohashi Medical Center
Tokyo, , Japan
Toyama University Hospital
Toyama, , Japan
Toyohashi Heart Center
Toyohashi, , Japan
University of Tsukuba Hospital
Tsukuba, , Japan
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Poznan University of Medical Sciences
Długa, Poznań, Poland
King Fahed Medical City- Prince Salman Cardiac Center
Riyadh, , Saudi Arabia
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital de Leon
León, , Spain
Hospital Clinico Salamanca
Salamanca, , Spain
University Hospital Zurich
Zurich, , Switzerland
Royal Sussex County Hospital
Brighton, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kar S, Doshi SK, Alkhouli M, Camm AJ, Coylewright M, Gibson MC, Granger CB, Gurol ME, Huber K, Mansour M, Nair DG, Natale A, Pocock SJ, Reddy VR, Saliba W, Christen T, Allocco DJ, Ellenbogen KA, Leon MB. Rationale and design of a randomized study comparing the Watchman FLX device to DOACs in patients with atrial fibrillation. Am Heart J. 2023 Oct;264:123-132. doi: 10.1016/j.ahj.2023.05.022. Epub 2023 Jun 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S2437
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.