Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1857 participants
INTERVENTIONAL
2024-10-01
2027-01-31
Brief Summary
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Detailed Description
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1. Aspirin only
2. Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)
3. DAPT
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Aspirin
Aspirin 81-100 mg, daily post implant for duration of the clinical trial
WATCHMAN FLX Pro LAAC Device
WATCHMAN FLX Pro LAAC Device Implantation
Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)
Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) for the first 3 months daily, post implant, followed by aspirin only for the duration of the clinical trial
WATCHMAN FLX Pro LAAC Device
WATCHMAN FLX Pro LAAC Device Implantation
DAPT
DAPT (aspirin 81-100 mg + clopidogrel 75 mg), for the first 6-months daily followed by aspirin only for the duration of the clinical trial
WATCHMAN FLX Pro LAAC Device
WATCHMAN FLX Pro LAAC Device Implantation
Interventions
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WATCHMAN FLX Pro LAAC Device
WATCHMAN FLX Pro LAAC Device Implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use.
* Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test 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
* Subject has a device margin residual leak \> 0mm at time of implant.
* Occurrence of complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure, post-procedure, or prior to randomization.
* Subject has a contraindication to one of the three protocol defined drug regimens.
* Subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy.
* Subject has known history of severe liver disease including cirrhosis with a Child-Pugh classification C or D.
* Subject with known hypercoagulability disorder, mechanical heart valve, rheumatic heart disease, or recurrent deep vein thrombosis.
* Subject has intracardiac thrombus, LAA sludge, or dense spontaneous echo contrast (SEC) observed during pre-implant imaging.
* Subject has Modified Rankin Score of ≥ 3 at baseline.
* Subject has left ventricular ejection fraction (LVEF) \< 30%.
* Subject with known amyloid cardiomyopathy.
* Platelet count ≤ 100,000 x 109/L.
* Subject has an estimated glomerular filtration rate (eGFR) \< 30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
* Subject has a stroke (of any cause, whether ischemic or hemorrhagic) within 30 days prior to implant or prior to randomization.
* Subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to implant or prior to randomization.
* Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 6-months after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.).
* Subject has a major bleeding event per International Society on Thrombosis and Haemostasis (ISTH) definitions within the 30 days prior to implant or 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.
* Subject has an active bleed.
* Subject has a cardiac tumor.
* Subject has signs/symptoms of acute or chronic pericarditis.
* Subject has an active infection.
* There is evidence of tamponade physiology.
* Subject has New York Heart Association Class IV congestive heart failure at the time of implant or prior to randomization.
* Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
* Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
* Subject has a documented life expectancy of less than 12 months.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Vivek Reddy, MD
Role: STUDY_CHAIR
Icahn School of Medicine at Mount Sinai
Saibal Kar, MD
Role: PRINCIPAL_INVESTIGATOR
Los Robles Health System
Walid Saliba, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Grandview Medical Center
Birmingham, Alabama, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
HonorHealth Heart Group - Shea
Scottsdale, Arizona, United States
Tucson Medical Center Healthcare
Tucson, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Mills Peninsula Health Services
Burlingame, California, United States
John Muir Medical Center
Concord, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
St. John's Health Center
Los Angeles, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
Cardiology Associates Medical Group
Ventura, California, United States
Colorado Heart and Vascular PC
Lakewood, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Washington Hospital
Washington D.C., District of Columbia, United States
Baptist Medical Center
Jacksonville, Florida, United States
HCA Florida Mercy Hospital
Miami, Florida, United States
Naples Community Hospital
Naples, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Georgia Arrhythmia Consultants
Macon, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Straub Medical Center
Honolulu, Hawaii, United States
St. Luke's Boise Medical Center
Boise, Idaho, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Evanston Hospital
Evanston, Illinois, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Community Heart and Vascular Hospita
Indianapolis, Indiana, United States
Mercy Hospital Medical Center
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Norton Hospital
Louisville, Kentucky, United States
Charlton Memorial
Fall River, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
M Health Fairview St John's Hospital
Maplewood, Minnesota, United States
Mayo Clinic Foundation
Rochester, Minnesota, United States
Centracare Heart and Vascular Center
Saint Cloud, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
St. Luke's Hospital
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper Hospital - University Medical Center
Camden, New Jersey, United States
Virtua Health
Marlton, New Jersey, United States
Valley Hospital
Paramus, New Jersey, United States
Lovelace Medical Center
Albuquerque, New Mexico, United States
Northwell Health
Bay Shore, New York, United States
Kaleida Health
Buffalo, New York, United States
New York University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Rex Hospital
Raleigh, North Carolina, United States
Wake Medical Center
Raleigh, North Carolina, United States
Bethesda North Hospital-Hospital
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Legacy Emanuel Hospital & Health Center
Portland, Oregon, United States
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, United States
Trident Medical Center
Charleston, South Carolina, United States
Prisma Health
Columbia, South Carolina, United States
MUSC Health Columbia Medical Center Downtown
Columbia, South Carolina, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
St. Thomas Heart
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States
Orion Medical
Houston, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
Christus Trinity Mother Frances Health System-Hospital
Tyler, Texas, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Chippenham & Johnston-Willis Hospital
Richmond, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Monongalia General Hospital
Morgantown, West Virginia, United States
Bellin Health
Green Bay, Wisconsin, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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S2508
Identifier Type: -
Identifier Source: org_study_id
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