Clinical trial NCT04394546: CHAMPION-AF Clinical Trial
Official title: WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Bleeding
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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").

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)

Primary outcomes:
measure: WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism
timeFrame: 36-months
measure: WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)
timeFrame: 36-months
measure: WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism
timeFrame: 60-months
Secondary outcomes:
measure: The occurrence of ISTH major bleeding
timeFrame: 60-months
measure: The occurrence of cardiovascular (CV) death, all stroke, systemic embolism (SE), and non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)
timeFrame: 60-months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare - Shea
state: Arizona
city: Tucson
country: United States
facility: Tucson Medical Center Healthcare
state: Arizona
city: Jonesboro
country: United States
facility: Arrythmia Research Group
state: Arkansas
city: Chula Vista
country: United States
facility: Sharp Chula Vista Medical Center
state: California
city: Greenbrae
country: United States
facility: Marin General Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Los Robles Hospital and Medical Center
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Santa Monica
country: United States
facility: St. John's Health Center
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Cardiologist, P.C.
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Brandon
country: United States
facility: Bay Area Cardiology Associates, P.A.
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health Indianapolis
state: Indiana
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Hospital
state: Massachusetts
city: Fall River
country: United States
facility: Charlton Memorial
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Health System - Sparrow Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Foundation
state: Minnesota
city: Saint Cloud
country: United States
facility: Centracare Heart and Vascular Center
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Omaha
country: United States
facility: Bergan Cardiology
state: Nebraska
city: Omaha
country: United States
facility: The Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute-Riverside Methodist Hospital
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Portland
country: United States
facility: Legacy Emanuel Hospital & Health Center
state: Oregon
city: Harrisburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Columbia
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Germantown
country: United States
facility: Methodist Le Bonheur Healthcare
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Memorial City Medical Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Health System
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Tacoma
country: United States
facility: CHI Franciscan Health System
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
city: Morgantown
country: United States
facility: Monongalia General Hospital
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital-Sydney
state: New South Wales
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Bella Vista
country: Australia
facility: Westmead Hospital
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis
city: Charleroi
country: Belgium
facility: CHU de Charleroi
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Québec
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Bron
country: France
facility: Hopital Cardiologique de Lyon
city: Grenoble
country: France
facility: CHU Grenoble-Hopital Michallon
city: Paris
country: France
facility: Hospital de la Pitie-Salpetriere
city: Berlin
country: Germany
facility: Charite, Campus Benjamin Franklin
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH
city: Erfurt
country: Germany
facility: St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen
city: Frankfurt
country: Germany
facility: St. Katharinen Krankenhaus
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg Praxis Wandsbek
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitat
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Pisa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio
state: PI
city: Florence
country: Italy
facility: Azienda Ospedaliera Careggi
city: Rivoli
country: Italy
facility: Ospedale Degli Infermi
city: Rozzano
country: Italy
facility: Instituto Clinico Humanitas
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
state: Chiba
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
state: Iwate-ken
city: Chiyoda-ku
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo
city: Okamoto
country: Japan
facility: Shonan Kamakura General Hospital
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Tokyo
country: Japan
facility: Toho University Ohashi Medical Center
city: Toyama-shi
country: Japan
facility: Toyama University Hospital
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Długa
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
city: Riyadh
country: Saudi Arabia
facility: King Fahed Medical City- Prince Salman Cardiac Center
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
city: Leon
country: Spain
facility: Hospital de Leon
city: Salamanca
country: Spain
facility: Hospital Clinico Salamanca
city: Zürich
country: Switzerland
facility: University Hospital Zurich
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center
name: Marty Leon, MD
role: STUDY_CHAIR
affiliation: Virginia Commonwealth University
name: Kenneth A Ellenbogen, MD
role: STUDY_CHAIR
affiliation: Pacific Heart Institute and Providence St. John's Health Center
name: Shephal Doshi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HCA Healthhcare /Los Robles Health System
name: Saibal Kar, MD
role: PRINCIPAL_INVESTIGATOR
References: