CHAMPION-AF Clinical Trial | NCT04394546 | Trialant

CHAMPION-AF Clinical Trial | NCT04394546 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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)

Grandview Medical Center

Birmingham, Alabama 35243, United States

University of Alabama at Birmingham

Birmingham, Alabama 35294-6830, United States

Arizona Arrhythmia Research Center

Phoenix, Arizona 85016, United States

Phoenix Cardiovascular Research Group

Phoenix, Arizona 85018, United States

Scottsdale Healthcare - Shea

Scottsdale, Arizona 85258, United States

Tucson Medical Center Healthcare

Tucson, Arizona 85712, United States

Arrythmia Research Group

Jonesboro, Arkansas 72401, United States

Sharp Chula Vista Medical Center

Chula Vista, California 91911, United States

Marin General Hospital

Greenbrae, California 94904, United States

Scripps Memorial Hospital

La Jolla, California 92037, United States

Los Robles Hospital and Medical Center

Los Angeles, California 91360, United States

El Camino Hospital

Mountain View, California 94040, United States

Eisenhower Medical Center

Rancho Mirage, California 92270, United States

Mercy General Hospital

Sacramento, California 95819, United States

Santa Barbara Cottage Hospital

Santa Barbara, California 93105, United States

St. John's Health Center

Santa Monica, California 90404, United States

Colorado Springs Cardiologist, P.C.

Colorado Springs, Colorado 80923, United States

Yale University School of Medicine

New Haven, Connecticut 06473, United States

Christiana Hospital

Newark, Delaware 19718, United States

Washington Hospital Center

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

Manatee Memorial Hospital

Bradenton, Florida 34205, United States

Bay Area Cardiology Associates, P.A.

Brandon, Florida 33511, United States

Broward General Medical Center

Fort Lauderdale, Florida 33316, United States

St. Vincent's Medical Center

Jacksonville, Florida 32204, United States

Lakeland Regional Medical Center

Lakeland, Florida 33805, United States

Baptist Hospital of Miami

Miami, Florida 33176, United States

AdventHealth Orlando

Orlando, Florida 32803, United States

Tallahassee Memorial Hospital

Tallahassee, Florida 32308, United States

Piedmont Hospital

Atlanta, Georgia 30309, United States

Emory University Hospital

Atlanta, Georgia 30322, United States

Memorial Health University Medical Center

Savannah, Georgia 31404, United States

Northwestern Memorial Hospital

Chicago, Illinois 60611, United States

Advocate Christ Medical Center

Oak Lawn, Illinois 60453, United States

St. John's Hospital

Springfield, Illinois 62701, United States

Franciscan Health Indianapolis

Indianapolis, Indiana 46237, United States

Community Hospital

Munster, Indiana 46321, United States

Mercy Hospital Medical Center

Des Moines, Iowa 50314, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242, United States

University of Kansas Hospital

Kansas City, Kansas 66160, United States

Norton Hospital

Louisville, Kentucky 40202, United States

Massachusetts General Hospital

Boston, Massachusetts 02114, United States

Brigham and Women's Hospital

Boston, Massachusetts 02115, United States

Lahey Clinic Hospital

Burlington, Massachusetts 01805, United States

Charlton Memorial

Fall River, Massachusetts 02720, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts 01655, United States

Sparrow Health System - Sparrow Hospital

Lansing, Michigan 48912, United States

William Beaumont Hospital

Royal Oak, Michigan 48073, United States

Mercy Hospital

Coon Rapids, Minnesota 55433, United States

Mayo Clinic Foundation

Rochester, Minnesota 55905, United States

Centracare Heart and Vascular Center

Saint Cloud, Minnesota 56303, United States

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota 55102, United States

North Mississippi Medical Center

Tupelo, Mississippi 38801, United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri 64111, United States

Billings Clinic

Billings, Montana 59101, United States

Bergan Cardiology

Omaha, Nebraska 68124, United States

The Nebraska Medical Center

Omaha, Nebraska 68198, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756, United States

Catholic Medical Center

Manchester, New Hampshire 03102, United States

Englewood Hospital and Medical Center

Englewood, New Jersey 07631, United States

Kaleida Health

Buffalo, New York 14203, United States

Mount Sinai Medical Center

New York, New York 10029, United States

Columbia University Medical Center

New York, New York 10032, United States

Rochester General Hospital

Rochester, New York 14621, United States

St. Francis Hospital

Roslyn, New York 11576, United States

Novant Health Presbyterian Medical Center

Charlotte, North Carolina 28204, United States

University Hospitals of Cleveland

Cleveland, Ohio 44106, United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195, United States

OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

Columbus, Ohio 43214, United States

Kettering Medical Center

Kettering, Ohio 45429, United States

The Toledo Hospital

Toledo, Ohio 43606, United States

Legacy Emanuel Hospital & Health Center

Portland, Oregon 97227, United States

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania 17101, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213, United States

York Hospital

York, Pennsylvania 17403, United States

Trident Medical Center

Charleston, South Carolina 29406, United States

Medical University of South Carolina

Columbia, South Carolina 29204, United States

Lexington Medical Center

West Columbia, South Carolina 29169, United States

Erlanger Medical Center

Chattanooga, Tennessee 37403, United States

Methodist Le Bonheur Healthcare

Germantown, Tennessee 38138, United States

Centennial Medical Center

Nashville, Tennessee 37203, United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232-7235, United States

Texas Cardiac Arrhythmia Research

Austin, Texas 78705, United States

Heart Hospital of Austin

Austin, Texas 78756, United States

Memorial Hermann Memorial City Medical Center

Houston, Texas 77024, United States

The Heart Hospital Baylor Plano

Plano, Texas 75093, United States

Methodist Texsan Hospital

San Antonio, Texas 78201-2009, United States

Christus Trinity Mother Frances Health System

Tyler, Texas 75701, United States

Inova Fairfax Hospital

Falls Church, Virginia 22042, United States

Virginia Commonwealth University Health System

Richmond, Virginia 23219, United States

Providence Regional Medical Center Everett

Everett, Washington 98201, United States

Swedish Medical Center

Seattle, Washington 98122, United States

CHI Franciscan Health System

Tacoma, Washington 98405, United States

PeaceHealth Southwest Medical

Vancouver, Washington 98668, United States

Monongalia General Hospital

Morgantown, West Virginia 26505, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin 52315, United States

St. Vincent's Hospital-Sydney

Darlinghurst, New South Wales, Australia

Monash Medical Centre

Clayton, Victoria 3168, Australia

Westmead Hospital

Bella Vista, Australia

Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, 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, 8200, Denmark

Hopital Cardiologique de Lyon

Bron, France

CHU Grenoble-Hopital Michallon

Grenoble, 38043, France

Hospital de la Pitie-Salpetriere

Paris, 75151, 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, 60389, 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 56126, Italy

Azienda Ospedaliera Careggi

Florence, Italy

Ospedale Degli Infermi

Rivoli, 10098, Italy

Instituto Clinico Humanitas

Rozzano, Italy

Chiba University Hospital

Chiba, Chiba, Japan

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka 802-8555, Japan

Iwate Medical University Hospital

Shiwa-gun, Iwate 028-3695, 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, 24071, Spain

Hospital Clinico Salamanca

Salamanca, Spain

University Hospital Zurich

Zurich, 8091, Switzerland

Royal Sussex County Hospital

Brighton, United Kingdom

Glenfield Hospital

Leicester, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom