CHAMPION-AF Clinical Trial (CHAMPION-AF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Atrial Fibrillation; Bleeding
• Intervention / Treatment: Device: WATCHMAN FLX LAAC Device; Drug: Non-Vitamin K Oral Anticoagulant

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").

• Study Type: Interventional
• Enrollment (Actual): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Bella Vista, Australia
    • Westmead Hospital
  • New South Wales
    • Darlinghurst, New South Wales, Australia
      • St. Vincent's Hospital-Sydney
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouw Ziekenhuis
  • Charleroi, Belgium
    • CHU de Charleroi
• Canada
  • Québec, Canada
    • Institut Universitaire de cardiologie et de pneumologie de Quebec
  • Ontario
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital
• France
  • Bron, France
    • Hopital Cardiologique de Lyon
  • Grenoble, France, 38043
    • CHU Grenoble-Hopital Michallon
  • Paris, France, 75151
    • Hospital de la Pitie-Salpetriere
• Germany
  • Berlin, Germany
    • Charite, Campus Benjamin Franklin
  • Coburg, Germany
    • SANA Kliniken Oberfranken Coburg GmbH
  • Dresden, Germany
    • Herzzentrum Dresden GmbH
  • Erfurt, Germany
    • St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
  • Essen, Germany
    • Elisabeth Krankenhaus Essen
  • Frankfurt, Germany, 60389
    • St. Katharinen Krankenhaus
  • Hamburg, Germany
    • Cardiologicum Hamburg Praxis Wandsbek
  • Lübeck, Germany
    • Universitaetsklinikum Schleswig-Holstein
  • München, Germany
    • Klinikum der Ludwig-Maximilians-Universitat
• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Center
  • Ramat Gan, Israel
    • Sheba Medical Center
• Italy
  • Florence, Italy
    • Azienda Ospedaliera Careggi
  • Rivoli, Italy, 10098
    • Ospedale degli Infermi
  • Rozzano, Italy
    • Instituto Clinico Humanitas
  • PI
    • Pisa, PI, Italy, 56126
      • Fondazione Toscana Gabriele Monasterio
• Japan
  • Okamoto, Japan
    • Shonan Kamakura General Hospital
  • Okayama, Japan
    • Kurashiki Central Hospital
  • Tokyo, Japan
    • Toho University Ohashi Medical Center
  • Toyama, Japan
    • Toyama University Hospital
  • Toyohashi, Japan
    • Toyohashi Heart Center
  • Tsukuba, Japan
    • University of Tsukuba Hospital
  • Chiba
    • Chiba, Chiba, Japan
      • Chiba University Hospital
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan
      • Mitsui Memorial Hospital
• Netherlands
  • Nieuwegein, Netherlands
    • St. Antonius ziekenhuis
• Poland
  • Poznań
    • Długa, Poznań, Poland
      • Poznan University of Medical Sciences
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Fahed Medical City- Prince Salman Cardiac Center
• Spain
  • León, Spain, 24071
    • Hospital de Leon
  • Salamanca, Spain
    • Hospital Clinico Salamanca
  • Pontevedra
    • Vigo, Pontevedra, Spain
      • Hospital Alvaro Cunqueiro
• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich
• United Kingdom
  • Brighton, United Kingdom
    • Royal Sussex County Hospital
  • Leicester, United Kingdom
    • Glenfield Hospital
  • Oxford, United Kingdom
    • John Radcliffe Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
    • Birmingham, Alabama, United States, 35294-6830
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Arrhythmia Research Center
    • Phoenix, Arizona, United States, 85018
      • Phoenix Cardiovascular Research Group
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Healthcare - Shea
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center HealthCare
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrythmia Research Group
  • California
    • Chula Vista, California, United States, 91911
      • Sharp Chula Vista Medical Center
    • Greenbrae, California, United States, 94904
      • Marin General Hospital
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital
    • Los Angeles, California, United States, 91360
      • Los Robles Hospital and Medical Center
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
    • Santa Monica, California, United States, 90404
      • St. John's Health Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80923
      • Colorado Springs Cardiologist, P.C.
  • Connecticut
    • New Haven, Connecticut, United States, 06473
      • Yale University School of Medicine
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Bradenton, Florida, United States, 34205
      • Manatee Memorial Hospital
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology Associates, P.A.
    • Fort Lauderdale, Florida, United States, 33316
      • Broward General Medical Center
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Medical Center
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Springfield, Illinois, United States, 62701
      • St. John's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Health Indianapolis
    • Munster, Indiana, United States, 46321
      • Community Hospital
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mercy Hospital Medical Center
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Hospital
    • Fall River, Massachusetts, United States, 02720
      • Charlton Memorial
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Health System - Sparrow Hospital
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Foundation
    • Saint Cloud, Minnesota, United States, 56303
      • Centracare Heart and Vascular Center
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph's Hospital
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital of Kansas City
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • The Nebraska Medical Center
    • Omaha, Nebraska, United States, 68124
      • Bergan Cardiology
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center
  • New York
    • Buffalo, New York, United States, 14203
      • Kaleida Health
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
    • Columbus, Ohio, United States, 43214
      • OhioHealth Research and Innovation Institute-Riverside Methodist Hospital
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
    • Toledo, Ohio, United States, 43606
      • The Toledo Hospital
  • Oregon
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Hospital & Health Center
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • Pinnacle Health at Harrisburg Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Trident Medical Center
    • Columbia, South Carolina, United States, 29204
      • Medical University of South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Lexington Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
    • Germantown, Tennessee, United States, 38138
      • Methodist Le Bonheur Healthcare
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
    • Nashville, Tennessee, United States, 37232-7235
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research
    • Houston, Texas, United States, 77024
      • Memorial Hermann Memorial City Medical Center
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78201-2009
      • Methodist Texsan Hospital
    • Tyler, Texas, United States, 75701
      • Christus Trinity Mother Frances Health System
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Health System
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Tacoma, Washington, United States, 98405
      • CHI Franciscan Health System
    • Vancouver, Washington, United States, 98668
      • PeaceHealth Southwest Medical
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Monongalia General Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 52315
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Group; Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device	Device: WATCHMAN FLX LAAC Device; WATCHMAN FLX LAAC Device Implantation; Other Names: WATCHMAN FLX Left Atrial Appendage Closure Device
Active Comparator: Control Group; Randomized to non-vitamin K oral anticoagulant (NOAC)	Drug: Non-Vitamin K Oral Anticoagulant; Initiation or continuation of a NOAC drug; Other Names: NOAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism	non-inferiority	36-months
WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)	superiority	36-months
WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism	non-inferiority	60-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of ISTH major bleeding	superiority	60-months
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	60-months
The occurrence of ISTH Major Bleeding	Non-Inferiority	36-months
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	36-months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Chair: Marty Leon, MD, New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center; Study Chair: Kenneth A Ellenbogen, MD, Virginia Commonwealth University; Principal Investigator: Shephal Doshi, MD, Pacific Heart Institute and Providence St. John's Health Center; Principal Investigator: Saibal Kar, MD, HCA Healthhcare /Los Robles Health System

Publications and helpful links

General Publications

• 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.
• 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 Mar 28. doi: 10.1056/NEJMoa2517213. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 16, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Hemorrhage; N(4)-oleylcytosine arabinoside
• Other Study ID Numbers: S2437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes