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Atrial FibrillationCHAMPION-AFNCT04394546

CHAMPION-AF Clinical Trial

A study testing WATCHMAN FLX LAAC Device and Non-Vitamin K Oral Anticoagulant in people with Atrial Fibrillation and Stroke, run by Boston Scientific Corporation at 141 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Stroke, Bleeding
What is being tested?
WATCHMAN FLX LAAC Device and Non-Vitamin K Oral Anticoagulant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
141 sitesin 16 countries
Study dates
15 Oct 2020to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is of legal age to participate in the study per the laws of their respective geography
  • 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

Who cannot join

  • Subjects who are currently enrolled in another investigational study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
  • 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
Show all 27Show fewer
  • 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
  • Transthoracic Echo Exclusion Criteria:
  • 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)

Trial locations and contacts

141 sites in 16 countries.

141 sites in 16 countries

United States95 sites

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Texas Cardiac Arrhythmia Research

    Austin, Texas, 78705

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • Billings Clinic

    Billings, Montana, 59101

  • Grandview Medical Center

    Birmingham, Alabama, 35243

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-6830

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Manatee Memorial Hospital

    Bradenton, Florida, 34205

  • Bay Area Cardiology Associates, P.A.

    Brandon, Florida, 33511

  • Kaleida Health

    Buffalo, New York, 14203

  • Lahey Clinic Hospital

    Burlington, Massachusetts, 01805

  • Trident Medical Center

    Charleston, South Carolina, 29406

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Sharp Chula Vista Medical Center

    Chula Vista, California, 91911

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Colorado Springs Cardiologist, P.C.

    Colorado Springs, Colorado, 80923

  • Medical University of South Carolina

    Columbia, South Carolina, 29204

  • OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mercy Hospital Medical Center

    Des Moines, Iowa, 50314

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • Charlton Memorial

    Fall River, Massachusetts, 02720

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Methodist Le Bonheur Healthcare

    Germantown, Tennessee, 38138

  • Marin General Hospital

    Greenbrae, California, 94904

  • Pinnacle Health at Harrisburg Hospital

    Harrisburg, Pennsylvania, 17101

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77024

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204

  • Arrythmia Research Group

    Jonesboro, Arkansas, 72401

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Scripps Memorial Hospital

    La Jolla, California, 92037

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Sparrow Health System - Sparrow Hospital

    Lansing, Michigan, 48912

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Los Robles Hospital and Medical Center

    Los Angeles, California, 91360

  • Norton Hospital

    Louisville, Kentucky, 40202

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 52315

  • Monongalia General Hospital

    Morgantown, West Virginia, 26505

  • El Camino Hospital

    Mountain View, California, 94040

  • Community Hospital

    Munster, Indiana, 46321

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-7235

  • Yale University School of Medicine

    New Haven, Connecticut, 06473

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Christiana Hospital

    Newark, Delaware, 19718

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Bergan Cardiology

    Omaha, Nebraska, 68124

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona, 85016

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Legacy Emanuel Hospital & Health Center

    Portland, Oregon, 97227

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Virginia Commonwealth University Health System

    Richmond, Virginia, 23219

  • Mayo Clinic Foundation

    Rochester, Minnesota, 55905

  • Rochester General Hospital

    Rochester, New York, 14621

  • St. Francis Hospital

    Roslyn, New York, 11576

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Mercy General Hospital

    Sacramento, California, 95819

  • Centracare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • Methodist Texsan Hospital

    San Antonio, Texas, 78201-2009

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • St. John's Health Center

    Santa Monica, California, 90404

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Scottsdale Healthcare - Shea

    Scottsdale, Arizona, 85258

  • Swedish Medical Center

    Seattle, Washington, 98122

  • St. John's Hospital

    Springfield, Illinois, 62701

  • CHI Franciscan Health System

    Tacoma, Washington, 98405

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • The Toledo Hospital

    Toledo, Ohio, 43606

  • PIMA Heart and Vascular

    Tucson, Arizona, 85741

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Christus Trinity Mother Frances Health System

    Tyler, Texas, 75701

  • PeaceHealth Southwest Medical

    Vancouver, Washington, 98668

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

  • York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Japan10 sites

  • Chiba University Hospital

    Chiba, Chiba

  • Mitsui Memorial Hospital

    Chiyoda-ku, Tokyo

  • Kokura Memorial Hospital

    Kitakyushu-shi, Fukuoka, 802-8555

  • Shonan Kamakura General Hospital

    Okamoto

  • Kurashiki Central Hospital

    Okayama

  • Iwate Medical University Hospital

    Shiwa-gun, Iwate, 028-3695

  • Toho University Ohashi Medical Center

    Tokyo

  • Toyama University Hospital

    Toyama

  • Toyohashi Heart Center

    Toyohashi

  • University of Tsukuba Hospital

    Tsukuba

Other trials in Japan

Germany9 sites

  • Charite, Campus Benjamin Franklin

    Berlin

  • SANA Kliniken Oberfranken Coburg GmbH

    Coburg

  • Herzzentrum Dresden GmbH

    Dresden

  • St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

    Erfurt

  • Elisabeth Krankenhaus Essen

    Essen

  • St. Katharinen Krankenhaus

    Frankfurt, 60389

  • Cardiologicum Hamburg Praxis Wandsbek

    Hamburg

  • Universitaetsklinikum Schleswig-Holstein

    Lübeck

  • Klinikum der Ludwig-Maximilians-Universitat

    München

Other trials in Germany

Italy4 sites

  • Azienda Ospedaliera Careggi

    Florence

  • Fondazione Toscana Gabriele Monasterio

    Pisa, PI, 56126

  • Ospedale Degli Infermi

    Rivoli, 10098

  • Instituto Clinico Humanitas

    Rozzano

Other trials in Italy

Australia3 sites

  • Westmead Hospital

    Bella Vista

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St. Vincent's Hospital-Sydney

    Darlinghurst, New South Wales

Other trials in Australia

France3 sites

  • Hopital Cardiologique de Lyon

    Bron

  • CHU Grenoble-Hopital Michallon

    Grenoble, 38043

  • Hospital de la Pitie-Salpetriere

    Paris, 75151

Other trials in France

Spain3 sites

  • Hospital de Leon

    León, 24071

  • Hospital Clinico Salamanca

    Salamanca

  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra

Other trials in Spain

United Kingdom3 sites

  • Royal Sussex County Hospital

    Brighton

  • Glenfield Hospital

    Leicester

  • John Radcliffe Hospital

    Oxford

Other trials in United Kingdom

Belgium2 sites

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, 9300

  • CHU de Charleroi

    Charleroi

Other trials in Belgium

Canada2 sites

  • Institut universitaire de Cardiologie et de Pneumologie de Quebec

    Québec

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

Other trials in Canada

Israel2 sites

  • Shaare Zedek Medical Center

    Jerusalem

  • Sheba Medical Center

    Ramat Gan

Other trials in Israel

Denmark1 site

  • Aarhus University Hospital

    Aarhus, 8200

Other trials in Denmark

Netherlands1 site

  • St. Antonius Ziekenhuis

    Nieuwegein

Other trials in Netherlands

Poland1 site

  • Poznan University of Medical Sciences

    Długa, Poznań

Other trials in Poland

Saudi Arabia1 site

  • King Fahed Medical City- Prince Salman Cardiac Center

    Riyadh

Other trials in Saudi Arabia

Switzerland1 site

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Read the detailed description

This study is a prospective, randomized, multi-center global investigation. Subjects will be randomized to either the WATCHMAN FLX Left Atrial Appendage Closure Device ("Device Group") or a commercially available non-vitamin K oral anticoagulant ("Control Group").

Being tested
WATCHMAN FLX LAAC Device, Non-Vitamin K Oral Anticoagulant
Medical subject headings
Atrial Fibrillation, Stroke, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WATCHMAN FLX LAAC DeviceDevice

    Also called WATCHMAN FLX Left Atrial Appendage Closure Device

    WATCHMAN FLX LAAC Device Implantation

  • Non-Vitamin K Oral AnticoagulantDrug

    Also called NOAC

    Initiation or continuation of a NOAC drug

Study groups in NCT04394546
Study groupRoleWhat they receive
Device GroupExperimentalRandomized to WATCHMAN FLX Left Atrial Appendage Closure Device
Receives: Device: WATCHMAN FLX LAAC Device
Control GroupActive comparatorRandomized to non-vitamin K oral anticoagulant (NOAC)
Receives: Drug: Non-Vitamin K Oral Anticoagulant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism

    non-inferiority

    Measured: 36-months

  2. WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)

    superiority

    Measured: 36-months

  3. WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism

    non-inferiority

    Measured: 60-months

Secondary outcomes (4)

  1. The occurrence of ISTH major bleeding

    superiority

    Measured: 60-months

  2. The occurrence of cardiovascular (CV) death, all stroke, systemic embolism (SE), and non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)

    superiority

    Measured: 60-months

  3. The occurrence of ISTH Major Bleeding

    Non-Inferiority

    Measured: 36-months

  4. The occurrence of cardiovascular (CV) death, all stroke, systemic embolism (SE), and non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)

    Non-inferiority

    Measured: 36-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2020
  2. Study start15 Oct 2020
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04394546
Sponsor's protocol ID
S2437
Acronym
CHAMPION-AF
Status last verified
Oct 2026
First submitted
14 May 2020
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Publications

  • Doshi SK, Kar S, Nair DG, Waggoner T, Agarwal H, Moussavian M, Kashani A, Oza S, Feldman L, Sadhu A, DeLurgio D, Alli O, Nielsen-Kudsk JE, Yamamoto M, Alkhouli M, Camm AJ, Coylewright M, Gibson CM, Granger CB, Gurol ME, Huber KC, Mansour M, Natale A, Pocock SJ, Reddy VY, Saliba WI, Asch FM, Wehrenberg S, Frost K, Christen T, Sutton BS, Stein KM, Leon MB, Ellenbogen KA; CHAMPION-AF Investigators. Left Atrial Appendage Closure or Anticoagulation for Atrial Fibrillation. N Engl J Med. 2026 Jun 4;394(21):2083-2094. doi: 10.1056/NEJMoa2517213. Epub 2026 Mar 28.

    PubMed 41910347

  • 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.

    PubMed 37279840

Questions about this trial

What is this clinical trial studying?

A study testing WATCHMAN FLX LAAC Device and Non-Vitamin K Oral Anticoagulant in people with Atrial Fibrillation and Stroke, run by Boston Scientific Corporation at 141 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States, Japan, Germany, Italy, Australia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism (time frame: 36-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04394546, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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