CHAMPION-AF Clinical Trial

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04394546
Collaborator
(none)
3,000
Enrollment
109
Locations
2
Arms
85.5
Anticipated Duration (Months)
27.5
Patients Per Site
0.3
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 with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Condition or DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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 [36-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) [36-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 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 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 ASD/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 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 LVEF < 30%

    • The subject has an existing pericardial effusion with a circumferential echo-free space > 5mm

    • The subject has a high-risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion > 15mm or length > 15mm

    • The subject has significant mitral valve stenosis (i.e., MV area <1.5 cm2)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Grandview Medical CenterBirminghamAlabamaUnited States35243
    2University of Alabama at BirminghamBirminghamAlabamaUnited States35294-6830
    3Phoenix Cardiovascular Research GroupPhoenixArizonaUnited States85018
    4Scottsdale Healthcare - SheaScottsdaleArizonaUnited States85258
    5Tucson Medical Center HealthcareTucsonArizonaUnited States85712
    6Arrythmia Research GroupJonesboroArkansasUnited States72401
    7Sharp Chula Vista Medical CenterChula VistaCaliforniaUnited States91911
    8Marin General HospitalGreenbraeCaliforniaUnited States94904
    9Los Robles Hospital and Medical CenterLos AngelesCaliforniaUnited States91360
    10El Camino HospitalMountain ViewCaliforniaUnited States94040
    11Eisenhower Medical CenterRancho MirageCaliforniaUnited States92270
    12Mercy General HospitalSacramentoCaliforniaUnited States95819
    13Santa Barbara Cottage HospitalSanta BarbaraCaliforniaUnited States93105
    14Colorado Springs Cardiologist, P.C.Colorado SpringsColoradoUnited States80932
    15Yale University School of MedicineNew HavenConnecticutUnited States06473
    16Christiana HospitalNewarkDelawareUnited States19718
    17Washington Hospital CenterWashingtonDistrict of ColumbiaUnited States20010
    18Bay Area Cardiology Associates, P.A.BrandonFloridaUnited States33511
    19Delray Medical CenterDelray BeachFloridaUnited States33484
    20Broward General Medical CenterFort LauderdaleFloridaUnited States33316
    21St. Vincent's Medical CenterJacksonvilleFloridaUnited States32204
    22Lakeland Regional Medical CenterLakelandFloridaUnited States33805
    23Baptist Hospital of MiamiMiamiFloridaUnited States33176
    24AdventHealth OrlandoOrlandoFloridaUnited States32803
    25Tallahassee Memorial HospitalTallahasseeFloridaUnited States32308
    26Emory University HospitalAtlantaGeorgiaUnited States30322
    27Memorial Health University Medical CenterSavannahGeorgiaUnited States31404
    28Northwestern Memorial HospitalChicagoIllinoisUnited States60611
    29Advocate Christ Medical CenterOak LawnIllinoisUnited States60453
    30St. John's HospitalSpringfieldIllinoisUnited States62701
    31Franciscan Health IndianapolisIndianapolisIndianaUnited States46237
    32Community HospitalMunsterIndianaUnited States14213
    33Mercy Hospital Medical CenterDes MoinesIowaUnited States50314
    34University of Iowa Hospitals and ClinicsIowa CityIowaUnited States52242
    35University of Kansas HospitalKansas CityKansasUnited States66160
    36Overland Park Regional Medical CenterOverland ParkKansasUnited States66215
    37Norton HospitalLouisvilleKentuckyUnited States40202
    38Massachusetts General HospitalBostonMassachusettsUnited States02114
    39Lahey Clinic HospitalBurlingtonMassachusettsUnited States01805
    40Charlton MemorialFall RiverMassachusettsUnited States02720
    41University of Massachusetts Memorial Medical CenterWorcesterMassachusettsUnited States01655
    42Sparrow Health System - Sparrow HospitalLansingMichiganUnited States48912
    43Mercy HospitalCoon RapidsMinnesotaUnited States55433
    44Mayo Clinic FoundationRochesterMinnesotaUnited States55905
    45Centracare Heart and Vascular CenterSaint CloudMinnesotaUnited States56303
    46HealthEast St. Joseph's HospitalSaint PaulMinnesotaUnited States55102
    47North Mississippi Medical CenterTupeloMississippiUnited States38801
    48St. Luke's Hospital of Kansas CityKansas CityMissouriUnited States64111
    49Billings ClinicBillingsMontanaUnited States59101
    50Bergan CardiologyOmahaNebraskaUnited States68124
    51The Nebraska Medical CenterOmahaNebraskaUnited States68198
    52Dartmouth Hitchcock Medical CenterLebanonNew HampshireUnited States03756
    53Catholic Medical CenterManchesterNew HampshireUnited States03102
    54Englewood Hospital and Medical CenterEnglewoodNew JerseyUnited States07631
    55Kaleida HealthBuffaloNew YorkUnited States14213
    56New York University Medical CenterNew YorkNew YorkUnited States10016
    57Mount Sinai Medical CenterNew YorkNew YorkUnited States10029
    58Columbia University Medical Center/New York Presbyterian HospitalNew YorkNew YorkUnited States10032
    59Rochester General HospitalRochesterNew YorkUnited States14621
    60St. Francis HospitalRoslynNew YorkUnited States11576
    61Novant Health Presbyterian Medical CenterCharlotteNorth CarolinaUnited States28204
    62University Hospitals of ClevelandClevelandOhioUnited States44106
    63Cleveland Clinic FoundationClevelandOhioUnited States44195
    64Kettering Medical CenterKetteringOhioUnited States45429
    65The Toledo HospitalToledoOhioUnited States43606
    66Legacy Emanuel Hospital & Health CenterPortlandOregonUnited States97227
    67Pinnacle Health at Harrisburg HospitalHarrisburgPennsylvaniaUnited States17101
    68University of Pittsburgh Medical CenterPittsburghPennsylvaniaUnited States15213
    69York HospitalYorkPennsylvaniaUnited States17403
    70Trident Medical CenterCharlestonSouth CarolinaUnited States29406
    71Lexington Medical CenterWest ColumbiaSouth CarolinaUnited States29169
    72Erlanger Medical CenterChattanoogaTennesseeUnited States37403
    73Centennial Medical CenterNashvilleTennesseeUnited States37203
    74Vanderbilt University Medical CenterNashvilleTennesseeUnited States37232-7235
    75Texas Cardiac Arrhythmia ResearchAustinTexasUnited States78705
    76Heart Hospital of AustinAustinTexasUnited States78756
    77Memorial Hermann Memorial City Medical CenterHoustonTexasUnited States77024
    78The Heart Hospital Baylor PlanoPlanoTexasUnited States75093
    79Methodist Texsan HospitalSan AntonioTexasUnited States78201-2009
    80Christus Trinity Mother Frances Health SystemTylerTexasUnited States75701
    81Inova Fairfax HospitalFalls ChurchVirginiaUnited States22042
    82CHI Franciscan Health SystemTacomaWashingtonUnited States98405
    83PeaceHealth Southwest MedicalVancouverWashingtonUnited States98668
    84Monongalia General HospitalMorgantownWest VirginiaUnited States26505
    85Aurora St. Luke's Medical CenterMilwaukeeWisconsinUnited States52315
    86Onze Lieve Vrouw ZiekenhuisAalstBelgium9300
    87Sunnybrook Health Sciences CentreTorontoOntarioCanada
    88Institut universitaire de Cardiologie et de Pneumologie de QuebecQuébecCanada
    89Aarhus University HospitalAarhusDenmark8200
    90Hopital Cardiologique de LyonBronFrance
    91CHRU de Clermont-FerrandClermont-FerrandFrance63000
    92Hôpital Privé Jacques CartierMassyFrance
    93Hopital BichatParisFrance
    94St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbHErfurtGermany
    95St. Katharinen KrankenhausFrankfurtGermany60389
    96Fondazione Toscana Gabriele MonasterioPisaPIItaly56126
    97Azienda Ospedaliera CareggiFlorenceItaly
    98Centro Cardiologico MonzinoMilanoItaly
    99Ospedale Degli InfermiRivoliItaly10098
    100Kokura Memorial HospitalKitakyushu-shiFukuokaJapan802-8555
    101Iwate Medical University HospitalShiwa-gunIwate-kenJapan028-3695
    102Mitsui Memorial HospitalChiyoda-kuTokyoJapan
    103Toyohashi Heart CenterToyohashiJapan
    104St. Antonius ZiekenhuisNieuwegeinNetherlands
    105University Hospital of Lord's TransfigurationDługaPoznańPoland
    106Hospital Álvaro CunqueiroVigoPontevedraSpain
    107Hospital de LeonLeonSpain24071
    108University Hospital ZurichZürichSwitzerland8091
    109Royal Sussex County Hospital SussexBrightonUnited 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:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    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:

    Study Results

    No Results Posted as of Nov 17, 2021