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CHAMPION-AF Clinical Trial (CHAMPION-AF)

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ClinicalTrials.gov Identifier: NCT04394546
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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 disease Intervention/treatment Phase
Atrial Fibrillation Stroke Bleeding Device: WATCHMAN FLX LAAC Device Drug: Non-Vitamin K Oral Anticoagulant Not Applicable

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").

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 15, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


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 Name: 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 Name: NOAC




Primary Outcome Measures :
  1. WATCHMAN FLX is non-inferior (NI) for the occurrence of stroke, cardiovascular death, and systemic embolism [ Time Frame: 36-months ]
    non-inferiority

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

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


Secondary Outcome Measures :
  1. The occurrence of ISTH major bleeding [ Time Frame: 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) [ Time Frame: 36-months ]
    superiority



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394546


Contacts
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Contact: Kellie Windle 1-800-CARDIAC Kellie.Windle@bsci.com

Locations
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United States, Alabama
Grandview Medical Center Recruiting
Birmingham, Alabama, United States, 35243
Contact: Susan Thorington    205-971-7578    susan.thorington@grandviewhealth.com   
Principal Investigator: Jose Osorio, MD         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-6830
Contact: Jane Vines    205-975-4335    jsnowden@uabmc.edu   
Principal Investigator: Tom McElderry, MD         
United States, Arizona
Tucson Medical Center Recruiting
Tucson, Arizona, United States, 85712
Contact: Natalia Elias Calles    520-324-5512    natalia.eliascalles@tmcaz.com   
Principal Investigator: Thomas Waggoner, MD         
United States, Arkansas
St. Bernard's Heart & Vascular Center Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Kayla Rubino, RN    870-935-6729    krubino@stbheart.com   
Principal Investigator: Devi Nair, MD         
United States, California
Los Robles Medical Center Recruiting
Los Angeles, California, United States, 91360
Contact: Mane Arabyan    805-796-3746    mane.arabyan@sarahcannon.com   
Principal Investigator: Saibal Kar, MD         
United States, Georgia
Emory University Medical Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Paige Smith    404-686-7992    pfsmith@emory.edu   
Principal Investigator: David DeLurgio, MD         
United States, Iowa
Mercy Hospital Medical Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Jennifer Young    515-633-3841    jyoung@iowaheart.com   
Principal Investigator: Robert Hoyt, MD         
United States, Massachusetts
Charlton Memorial Hospital Recruiting
Fall River, Massachusetts, United States, 02720
Contact: Debra Benevides    508-973-7775    benevidesd@southcoast.org   
Principal Investigator: Adam Saltzman, MD         
United States, Nebraska
Bergan Cardiology Recruiting
Omaha, Nebraska, United States, 68124
Contact: Barbara Lapke    402-343-8511    barbara.lapke@alegent.org   
Principal Investigator: Himanshu Agarwal, MD         
United States, New York
New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: April Jacob    212-263-7704    april.jacob@nyulangone.org   
Principal Investigator: Larry Chinitz, MD         
Columbia University Medical Center/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Suzanne Edwards    212-342-5182    sme2146@cumc.columbia.edu   
Principal Investigator: Robert Sommer, MD         
United States, South Carolina
Trident Medical Center Recruiting
Charleston, South Carolina, United States, 29406
Contact: Tina Cooper    843-847-4129    tina.cooper@hcahealthcare.com   
Principal Investigator: Frank Cuoco, MD         
United States, Tennessee
Centennial Medical Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Molly Harper    615-354-7708    molly.harper@sarahcannon.com   
Principal Investigator: Samuel Horr, MD         
United States, Texas
Texas Cardiac Arrhythmia Research Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal    512-431-4868    dscardinal@austinheartbeat.com   
Principal Investigator: Rodney Horton, MD         
Heart Hospital of Austin Recruiting
Austin, Texas, United States, 78756
Contact: Maurene Cantu    512-421-3870    maurene.cantu@stdavids.com   
Principal Investigator: Juhana Karha, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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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
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04394546    
Other Study ID Numbers: S2437
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
URL: http://www.bostonscientific.com/content/gwc/en-US/data-sharing-requests.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants