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ACTIVE NOT RECRUITING

NCT04394546

CHAMPION-AF Clinical Trial

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2020-10-15

Completion Date

2027-12

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Atrial Fibrillation Stroke Bleeding

Interventions

DEVICE

WATCHMAN FLX LAAC Device

WATCHMAN FLX LAAC Device Implantation

DRUG

Non-Vitamin K Oral Anticoagulant

Initiation or continuation of a NOAC drug

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)

Locations (141)

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