CHAMPION-AF Clinical Trial
- Conditions
- StrokeBleedingAtrial Fibrillation
- Interventions
- Device: WATCHMAN FLX LAAC DeviceDrug: Non-Vitamin K Oral Anticoagulant
- Registration Number
- NCT04394546
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- 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").
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device Group WATCHMAN FLX LAAC Device Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device Control Group Non-Vitamin K Oral Anticoagulant Randomized to non-vitamin K oral anticoagulant (NOAC)
- Primary Outcome Measures
Name Time Method WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism 36-months non-inferiority
WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) 36-months superiority
WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism 60-months non-inferiority
- Secondary Outcome Measures
Name Time Method The occurrence of ISTH major bleeding 60-months superiority
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 superiority
Trial Locations
- Locations (141)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mitsui Memorial Hospital
🇯🇵Chiyoda-ku, Tokyo, Japan
Sharp Chula Vista Medical Center
🇺🇸Chula Vista, California, United States
Tucson Medical Center Healthcare
🇺🇸Tucson, Arizona, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Marin General Hospital
🇺🇸Greenbrae, California, United States
Los Robles Hospital and Medical Center
🇺🇸Los Angeles, California, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
El Camino Hospital
🇺🇸Mountain View, California, United States
Santa Barbara Cottage Hospital
🇺🇸Santa Barbara, California, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
St. John's Health Center
🇺🇸Santa Monica, California, United States
Colorado Springs Cardiologist, P.C.
🇺🇸Colorado Springs, Colorado, United States
Washington Hospital Center
🇺🇸Washington, 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
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
St. Vincent's Medical Center
🇺🇸Jacksonville, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, 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
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Lahey Clinic Hospital
🇺🇸Burlington, Massachusetts, United States
Charlton Memorial
🇺🇸Fall River, 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
HealthEast St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Centracare Heart and Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Kaleida Health
🇺🇸Buffalo, New York, United States
Columbia University Medical Center
🇺🇸New York, 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
OhioHealth Research and Innovation Institute-Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Pinnacle Health at Harrisburg Hospital
🇺🇸Harrisburg, Pennsylvania, United States
York Hospital
🇺🇸York, Pennsylvania, 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
Memorial Hermann Memorial City Medical Center
🇺🇸Houston, Texas, United States
Christus Trinity Mother Frances Health System
🇺🇸Tyler, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
PeaceHealth Southwest Medical
🇺🇸Vancouver, Washington, United States
CHI Franciscan Health System
🇺🇸Tacoma, Washington, United States
St. Vincent's Hospital-Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Monongalia General Hospital
🇺🇸Morgantown, West Virginia, United States
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Westmead Hospital
🇦🇺Bella Vista, Australia
CHU de Charleroi
🇧🇪Charleroi, Belgium
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
🇨🇦Québec, Canada
Hopital Cardiologique de Lyon
🇫🇷Bron, France
Aarhus University Hospital
🇩🇰Aarhus, Denmark
CHU Grenoble-Hopital Michallon
🇫🇷Grenoble, France
Hospital de la Pitie-Salpetriere
🇫🇷Paris, France
Klinikum Coburg GmbH
🇩🇪Coburg, Germany
Charite, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Herzzentrum Dresden GmbH
🇩🇪Dresden, Germany
Elisabeth Krankenhaus Essen
🇩🇪Essen, Germany
St. Katharinen Krankenhaus
🇩🇪Frankfurt, Germany
Cardiologicum Hamburg Praxis Wandsbek
🇩🇪Hamburg, Germany
Universitaetsklinikum Schleswig-Holstein
🇩🇪Luebeck, Germany
Klinikum der Ludwig-Maximilians-Universitat
🇩🇪München, Germany
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Azienda Ospedaliera Careggi
🇮🇹Florence, Italy
Chiba University Hospital
🇯🇵Chiba-shi, Chiba, Japan
Kokura Memorial Hospital
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Iwate Medical University Hospital
🇯🇵Shiwa-gun, Iwate-ken, Japan
Shonan Kamakura General Hospital
🇯🇵Okamoto, Japan
Toho University Ohashi Medical Center
🇯🇵Tokyo, Japan
Kurashiki Central Hospital
🇯🇵Okayama, 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
🇪🇸Leon, Spain
University Hospital Zurich
🇨🇭Zürich, Switzerland
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Glenfield Hospital
🇬🇧Leicester, United Kingdom
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Scottsdale Healthcare - Shea
🇺🇸Scottsdale, Arizona, United States
Englewood Hospital and Medical Center
🇺🇸Englewood, New Jersey, United States
Arrythmia Research Group
🇺🇸Jonesboro, Arkansas, United States
Toyama University Hospital
🇯🇵Toyama-shi, Japan
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Onze Lieve Vrouw Ziekenhuis
🇧🇪Aalst, Belgium
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Methodist Texsan Hospital
🇺🇸San Antonio, Texas, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
Arizona Arrhythmia Research Center
🇺🇸Phoenix, Arizona, United States
Hospital Clinico Salamanca
🇪🇸Salamanca, Spain
Fondazione Toscana Gabriele Monasterio
🇮🇹Pisa, PI, Italy
Ospedale Degli Infermi
🇮🇹Rivoli, Italy
Instituto Clinico Humanitas
🇮🇹Rozzano, Italy
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Grandview Medical Center
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Foundation
🇺🇸Rochester, Minnesota, United States
Bergan Cardiology
🇺🇸Omaha, Nebraska, United States
The Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Legacy Emanuel Hospital & Health Center
🇺🇸Portland, Oregon, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
🇩🇪Erfurt, Germany
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Norton Hospital
🇺🇸Louisville, Kentucky, United States
St. Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Trident Medical Center
🇺🇸Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research
🇺🇸Austin, Texas, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States