CHAMPION-AF Clinical Trial

Stroke Clinical Trial

— CHAMPION-AF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04394546
• Other study ID #: S2437
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Bleeding
• Stroke

Intervention

Device:
• WATCHMAN FLX LAAC Device
WATCHMAN FLX LAAC Device Implantation

Drug:
• Non-Vitamin K Oral Anticoagulant
Initiation or continuation of a NOAC drug

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Germany,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Saudi Arabia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism	non-inferiority	36-months
Primary	WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)	superiority	36-months
Primary	WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism	non-inferiority	60-months
Secondary	The occurrence of ISTH major bleeding	superiority	60-months
Secondary	The occurrence of cardiovascular (CV) death, all stroke, systemic embolism (SE), and non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding)	superiority	60-months