CHAMPION-AF Clinical Trial

NCT04394546 | Active Not Recruiting DMC FDA Device

• 1 other identifier: S2437
• Study Type: interventional
• Target: 3,000
• Locations: 16 countries
• Sites: 141

Brief 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.

Conditions

Atrial Fibrillation; Stroke; Bleeding

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• The occurrence of ISTH major bleeding

  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)

  60-months

• The occurrence of ISTH Major Bleeding

  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)

  36-months

Study Arms (2)

Device Group

EXPERIMENTAL

Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device

Device: WATCHMAN FLX LAAC Device

Control Group

ACTIVE COMPARATOR

Randomized to non-vitamin K oral anticoagulant (NOAC)

Drug: Non-Vitamin K Oral Anticoagulant

Interventions

WATCHMAN FLX LAAC Device DEVICE

WATCHMAN FLX LAAC Device Implantation

Also known as: WATCHMAN FLX Left Atrial Appendage Closure Device

Device Group

Non-Vitamin K Oral Anticoagulant DRUG

Initiation or continuation of a NOAC drug

Also known as: NOAC

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (141)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-6830, United States

Location

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85016, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85258, United States

Location

Tucson Medical Center Healthcare

Tucson, Arizona, 85712, United States

Location

Arrythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Sharp Chula Vista Medical Center

Chula Vista, California, 91911, United States

Location

Marin General Hospital

Greenbrae, California, 94904, United States

Location

Scripps Memorial Hospital

La Jolla, California, 92037, United States

Location

Los Robles Hospital and Medical Center

Los Angeles, California, 91360, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

St. John's Health Center

Santa Monica, California, 90404, United States

Location

Colorado Springs Cardiologist, P.C.

Colorado Springs, Colorado, 80923, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06473, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34205, United States

Location

Bay Area Cardiology Associates, P.A.

Brandon, Florida, 33511, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

St. John's Hospital

Springfield, Illinois, 62701, United States

Location

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States

Location

Community Hospital

Munster, Indiana, 46321, United States

Location

Mercy Hospital Medical Center

Des Moines, Iowa, 50314, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Clinic Hospital

Burlington, Massachusetts, 01805, United States

Location

Charlton Memorial

Fall River, Massachusetts, 02720, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Sparrow Health System - Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

Location

Centracare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Bergan Cardiology

Omaha, Nebraska, 68124, United States

Location

The Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Kaleida Health

Buffalo, New York, 14203, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

The Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Legacy Emanuel Hospital & Health Center

Portland, Oregon, 97227, United States

Location

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, 17101, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Medical University of South Carolina

Columbia, South Carolina, 29204, United States

Location

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Methodist Le Bonheur Healthcare

Germantown, Tennessee, 38138, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-7235, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Methodist Texsan Hospital

San Antonio, Texas, 78201-2009, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23219, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

CHI Franciscan Health System

Tacoma, Washington, 98405, United States

Location

PeaceHealth Southwest Medical

Vancouver, Washington, 98668, United States

Location

Monongalia General Hospital

Morgantown, West Virginia, 26505, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 52315, United States

Location

St. Vincent's Hospital-Sydney

Darlinghurst, New South Wales, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Westmead Hospital

Bella Vista, Australia

Location

Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium

Location

CHU de Charleroi

Charleroi, Belgium

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Canada

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Hopital Cardiologique de Lyon

Bron, France

Location

CHU Grenoble-Hopital Michallon

Grenoble, 38043, France

Location

Hospital de la Pitie-Salpetriere

Paris, 75151, France

Location

Charite, Campus Benjamin Franklin

Berlin, Germany

Location

SANA Kliniken Oberfranken Coburg GmbH

Coburg, Germany

Location

Herzzentrum Dresden GmbH

Dresden, Germany

Location

St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

Erfurt, Germany

Location

Elisabeth Krankenhaus Essen

Essen, Germany

Location

St. Katharinen Krankenhaus

Frankfurt, 60389, Germany

Location

Cardiologicum Hamburg Praxis Wandsbek

Hamburg, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Lübeck, Germany

Location

Klinikum der Ludwig-Maximilians-Universitat

München, Germany

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Fondazione Toscana Gabriele Monasterio

Pisa, PI, 56126, Italy

Location

Azienda Ospedaliera Careggi

Florence, Italy

Location

Ospedale Degli Infermi

Rivoli, 10098, Italy

Location

Instituto Clinico Humanitas

Rozzano, Italy

Location

Chiba University Hospital

Chiba, Chiba, Japan

Location

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, 802-8555, Japan

Location

Iwate Medical University Hospital

Shiwa-gun, Iwate, 028-3695, Japan

Location

Mitsui Memorial Hospital

Chiyoda-ku, Tokyo, Japan

Location

Shonan Kamakura General Hospital

Okamoto, Japan

Location

Kurashiki Central Hospital

Okayama, Japan

Location

Toho University Ohashi Medical Center

Tokyo, Japan

Location

Toyama University Hospital

Toyama, Japan

Location

Toyohashi Heart Center

Toyohashi, Japan

Location

University of Tsukuba Hospital

Tsukuba, Japan

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Poznan University of Medical Sciences

Długa, Poznań, Poland

Location

King Fahed Medical City- Prince Salman Cardiac Center

Riyadh, Saudi Arabia

Location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Location

Hospital de Leon

León, 24071, Spain

Location

Hospital Clinico Salamanca

Salamanca, Spain

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

Glenfield Hospital

Leicester, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 41910347 DERIVED

• 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.

  PMID: 37279840 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Hemorrhage

Interventions

N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Marty Leon, MD

  New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center

  STUDY CHAIR

• Kenneth A Ellenbogen, MD

  Virginia Commonwealth University

  STUDY CHAIR

• Shephal Doshi, MD

  Pacific Heart Institute and Providence St. John's Health Center

  PRINCIPAL INVESTIGATOR

• Saibal Kar, MD

  HCA Healthhcare /Los Robles Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: October 15, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

AU (3); CH (1); FR (3); US (95); GB (3); IL (2); PL (1); CA (2); IT (4); SA (1); ES (3); JP (10); DE (9); NL (1); DK (1); BE (2)