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CHAMPION-AF Clinical Trial

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04394546
Collaborator
(none)
3,000
Enrollment
154
Locations
2
Arms
85.5
Anticipated Duration (Months)
19.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: WATCHMAN FLX LAAC Device
  • Drug: Non-Vitamin K Oral Anticoagulant
 N/A

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").

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation
Actual Study Start Date :
Oct 15, 2020
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Device Group

Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device

Device: WATCHMAN FLX LAAC Device
WATCHMAN FLX LAAC Device Implantation
Other Names:
  • WATCHMAN FLX Left Atrial Appendage Closure Device

    		•
    Active Comparator: Control Group

    Randomized to non-vitamin K oral anticoagulant (NOAC)

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism [36-months]

      non-inferiority

    2. WATCHMAN FLX is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) [36-months]

      superiority

    3. WATCHMAN FLX is non-inferior (NI) for the occurrence of ischemic stroke and systemic embolism [60-months]

      non-inferiority

    Secondary Outcome Measures

    1. The occurrence of ISTH major bleeding [60-months]

      superiority

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Grandview Medical Center Birmingham Alabama United States 35243
    2 University of Alabama at Birmingham Birmingham Alabama United States 35294-6830
    3 Arizona Arrhythmia Research Center Phoenix Arizona United States 85016
    4 Phoenix Cardiovascular Research Group Phoenix Arizona United States 85018
    5 Scottsdale Healthcare - Shea Scottsdale Arizona United States 85258
    6 Tucson Medical Center Healthcare Tucson Arizona United States 85712
    7 Arrythmia Research Group Jonesboro Arkansas United States 72401
    8 Sharp Chula Vista Medical Center Chula Vista California United States 91911
    9 Marin General Hospital Greenbrae California United States 94904
    10 Scripps Memorial Hospital La Jolla California United States 92037
    11 Cedars-Sinai Medical Center Los Angeles California United States 90048
    12 Los Robles Hospital and Medical Center Los Angeles California United States 91360
    13 El Camino Hospital Mountain View California United States 94040
    14 Eisenhower Medical Center Rancho Mirage California United States 92270
    15 Mercy General Hospital Sacramento California United States 95819
    16 Santa Barbara Cottage Hospital Santa Barbara California United States 93105
    17 St. John's Health Center Santa Monica California United States 90404
    18 Colorado Springs Cardiologist, P.C. Colorado Springs Colorado United States 80932
    19 Yale University School of Medicine New Haven Connecticut United States 06473
    20 Christiana Hospital Newark Delaware United States 19718
    21 Washington Hospital Center Washington District of Columbia United States 20010
    22 Manatee Memorial Hospital Bradenton Florida United States 34208
    23 Bay Area Cardiology Associates, P.A. Brandon Florida United States 33511
    24 Delray Medical Center Delray Beach Florida United States 33484
    25 Broward General Medical Center Fort Lauderdale Florida United States 33316
    26 St. Vincent's Medical Center Jacksonville Florida United States 32204
    27 Lakeland Regional Medical Center Lakeland Florida United States 33805
    28 Baptist Hospital of Miami Miami Florida United States 33176
    29 AdventHealth Orlando Orlando Florida United States 32803
    30 Tallahassee Memorial Hospital Tallahassee Florida United States 32308
    31 Piedmont Hospital Atlanta Georgia United States 30309
    32 Emory University Hospital Atlanta Georgia United States 30322
    33 Memorial Health University Medical Center Savannah Georgia United States 31404
    34 Northwestern Memorial Hospital Chicago Illinois United States 60611
    35 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
    36 St. John's Hospital Springfield Illinois United States 62701
    37 Franciscan Health Indianapolis Indianapolis Indiana United States 46237
    38 Community Hospital Munster Indiana United States 14213
    39 Mercy Hospital Medical Center Des Moines Iowa United States 50314
    40 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    41 University of Kansas Hospital Kansas City Kansas United States 66160
    42 Overland Park Regional Medical Center Overland Park Kansas United States 66215
    43 Norton Hospital Louisville Kentucky United States 40202
    44 Massachusetts General Hospital Boston Massachusetts United States 02114
    45 Brigham and Women's Hospital Boston Massachusetts United States 02115
    46 Lahey Clinic Hospital Burlington Massachusetts United States 01805
    47 Charlton Memorial Fall River Massachusetts United States 02720
    48 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    49 Sparrow Health System - Sparrow Hospital Lansing Michigan United States 48912
    50 William Beaumont Hospital Royal Oak Michigan United States 48013
    51 Mercy Hospital Coon Rapids Minnesota United States 55433
    52 Mayo Clinic Foundation Rochester Minnesota United States 55905
    53 Centracare Heart and Vascular Center Saint Cloud Minnesota United States 56303
    54 HealthEast St. Joseph's Hospital Saint Paul Minnesota United States 55102
    55 North Mississippi Medical Center Tupelo Mississippi United States 38801
    56 St. Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    57 Billings Clinic Billings Montana United States 59101
    58 Bergan Cardiology Omaha Nebraska United States 68124
    59 The Nebraska Medical Center Omaha Nebraska United States 68198
    60 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    61 Catholic Medical Center Manchester New Hampshire United States 03102
    62 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
    63 Kaleida Health Buffalo New York United States 14213
    64 New York University Medical Center New York New York United States 10016
    65 Mount Sinai Medical Center New York New York United States 10029
    66 Columbia University Medical Center New York New York United States 10032
    67 Rochester General Hospital Rochester New York United States 14621
    68 St. Francis Hospital Roslyn New York United States 11576
    69 Novant Health Presbyterian Medical Center Charlotte North Carolina United States 28204
    70 University Hospitals of Cleveland Cleveland Ohio United States 44106
    71 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    72 OhioHealth Research and Innovation Institute-Riverside Methodist Hospital Columbus Ohio United States 43214
    73 Kettering Medical Center Kettering Ohio United States 45429
    74 The Toledo Hospital Toledo Ohio United States 43606
    75 Legacy Emanuel Hospital & Health Center Portland Oregon United States 97227
    76 Pinnacle Health at Harrisburg Hospital Harrisburg Pennsylvania United States 17101
    77 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    78 York Hospital York Pennsylvania United States 17403
    79 Trident Medical Center Charleston South Carolina United States 29406
    80 Medical University of South Carolina Columbia South Carolina United States 29204
    81 Lexington Medical Center West Columbia South Carolina United States 29169
    82 Erlanger Medical Center Chattanooga Tennessee United States 37403
    83 Methodist Le Bonheur Healthcare Germantown Tennessee United States 38138
    84 Centennial Medical Center Nashville Tennessee United States 37203
    85 St. Thomas Health Nashville Tennessee United States 37205
    86 Vanderbilt University Medical Center Nashville Tennessee United States 37232-7235
    87 Texas Cardiac Arrhythmia Research Austin Texas United States 78705
    88 Heart Hospital of Austin Austin Texas United States 78756
    89 Memorial Hermann Memorial City Medical Center Houston Texas United States 77024
    90 The Heart Hospital Baylor Plano Plano Texas United States 75093
    91 Methodist Texsan Hospital San Antonio Texas United States 78201-2009
    92 Christus Trinity Mother Frances Health System Tyler Texas United States 75701
    93 Inova Fairfax Hospital Falls Church Virginia United States 22042
    94 Virginia Commonwealth University Health System Richmond Virginia United States 23219
    95 Providence Regional Medical Center Everett Everett Washington United States 98201
    96 Swedish Medical Center Seattle Washington United States 98122
    97 CHI Franciscan Health System Tacoma Washington United States 98405
    98 PeaceHealth Southwest Medical Vancouver Washington United States 98668
    99 Monongalia General Hospital Morgantown West Virginia United States 26505
    100 Aurora St. Luke's Medical Center Milwaukee Wisconsin United States 52315
    101 St. Vincent's Hospital-Sydney Darlinghurst New South Wales Australia
    102 Monash Medical Centre Clayton Victoria Australia 3168
    103 The Alfred Hospital Melbourne Victoria Australia
    104 Westmead Hospital Bella Vista Australia
    105 Onze Lieve Vrouw Ziekenhuis Aalst Belgium 9300
    106 CHU de Charleroi Charleroi Belgium
    107 Sunnybrook Health Sciences Centre Toronto Ontario Canada
    108 Institut universitaire de Cardiologie et de Pneumologie de Quebec Québec Canada
    109 Aarhus University Hospital Aarhus Denmark 8200
    110 Hopital Cardiologique de Lyon Bron France
    111 CHRU de Clermont-Ferrand Clermont-Ferrand France 63000
    112 CHU Henri Mondor Créteil France
    113 CHU Grenoble-Hopital Michallon Grenoble France 38043
    114 Hôpital Privé Jacques Cartier Massy France
    115 Hospital de la Pitie-Salpetriere Paris France 75151
    116 Hopital Bichat Paris France
    117 Institut Mutualiste Montsouris Paris France
    118 CHU de Bordeaux Pessac France
    119 Charite, Campus Benjamin Franklin Berlin Germany
    120 Klinikum Coburg GmbH Coburg Germany
    121 Herzzentrum Dresden GmbH Dresden Germany
    122 St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH Erfurt Germany
    123 Elisabeth Krankenhaus Essen Essen Germany
    124 St. Katharinen Krankenhaus Frankfurt Germany 60389
    125 Cardiologicum Hamburg Praxis Wandsbek Hamburg Germany
    126 Universitaetsklinikum Schleswig-Holstein Luebeck Germany
    127 Klinikum der Ludwig-Maximilians-Universitat München Germany
    128 Shaare Zedek Medical Center Jerusalem Israel
    129 Sheba Medical Center Ramat Gan Israel
    130 Fondazione Toscana Gabriele Monasterio Pisa PI Italy 56126
    131 Azienda Ospedaliera Careggi Florence Italy
    132 Centro Cardiologico Monzino Milano Italy
    133 Ospedale Degli Infermi Rivoli Italy 10098
    134 Instituto Clinico Humanitas Rozzano Italy
    135 Chiba University Hospital Chiba-shi Chiba Japan
    136 Kokura Memorial Hospital Kitakyushu-shi Fukuoka Japan 802-8555
    137 Iwate Medical University Hospital Shiwa-gun Iwate-ken Japan 028-3695
    138 Mitsui Memorial Hospital Chiyoda-ku Tokyo Japan
    139 Shonan Kamakura General Hospital Okamoto Japan
    140 Kurashiki Central Hospital Okayama Japan
    141 Toho University Ohashi Medical Center Tokyo Japan
    142 Toyama University Hospital Toyama-shi Japan
    143 Toyohashi Heart Center Toyohashi Japan
    144 University of Tsukuba Hospital Tsukuba Japan
    145 St. Antonius Ziekenhuis Nieuwegein Netherlands
    146 Poznan University of Medical Sciences Długa Poznań Poland
    147 King Fahed Medical City- Prince Salman Cardiac Center Riyadh Saudi Arabia
    148 Hospital Álvaro Cunqueiro Vigo Pontevedra Spain
    149 Hospital de Leon Leon Spain 24071
    150 Hospital Clinico Salamanca Salamanca Spain
    151 University Hospital Zurich Zürich Switzerland 8091
    152 Royal Sussex County Hospital Brighton United Kingdom
    153 Glenfield Hospital Leicester United Kingdom
    154 John Radcliffe Hospital Oxford United Kingdom

    Sponsors and Collaborators

    • Boston Scientific Corporation

    Investigators

    • Study Chair: Marty Leon, MD, New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center
    • Study Chair: Kenneth A Ellenbogen, MD, Virginia Commonwealth University
    • Principal Investigator: Shephal Doshi, MD, Pacific Heart Institute and Providence St. John's Health Center
    • Principal Investigator: Saibal Kar, MD, HCA Healthhcare /Los Robles Health System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Scientific Corporation
    ClinicalTrials.gov Identifier:
    NCT04394546
    Other Study ID Numbers:
    • S2437
    First Posted:
    May 19, 2020
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Anticoagulants

    Study Results

    No Results Posted as of Jul 29, 2022