WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy
Status: Recruiting
Location: See all (87) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subject is of legal age to participate in the study per the laws of their respective geography.
• 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.
Locations
United States
Alabama
Grandview Medical Center
RECRUITING
Birmingham
University of Alabama Birmingham
RECRUITING
Birmingham
Arkansas
Arrhythmia Research Group
RECRUITING
Jonesboro
Arizona
Phoenix Cardiovascular Research Group
RECRUITING
Phoenix
HonorHealth Heart Group - Shea
RECRUITING
Scottsdale
Tucson Medical Center Healthcare
RECRUITING
Tucson
California
Mills Peninsula Health Services
RECRUITING
Burlingame
John Muir Medical Center
RECRUITING
Concord
Scripps Memorial Hospital
RECRUITING
La Jolla
Loma Linda University Medical Center
RECRUITING
Loma Linda
Santa Barbara Cottage Hospital
RECRUITING
Santa Barbara
Los Robles Hospital & Medical Center
RECRUITING
Thousand Oaks
Cardiology Associates Medical Group
RECRUITING
Ventura
Colorado
Colorado Heart and Vascular PC
RECRUITING
Lakewood
Medical Center of the Rockies
RECRUITING
Loveland
Connecticut
Hartford Hospital
RECRUITING
Hartford
Washington, D.c.
Washington Hospital
RECRUITING
Washington D.c.
Florida
Baptist Medical Center
RECRUITING
Jacksonville
HCA Florida Mercy Hospital
RECRUITING
Miami
Naples Community Hospital
RECRUITING
Naples
Sarasota Memorial Hospital
RECRUITING
Sarasota
Georgia
Emory University Hospital
RECRUITING
Atlanta
Georgia Arrhythmia Consultants
RECRUITING
Macon
Wellstar Kennestone Hospital
RECRUITING
Marietta
Memorial Health University Medical Center
RECRUITING
Savannah
Hawaii
Straub Medical Center
RECRUITING
Honolulu
Iowa
Mercy Hospital Medical Center
RECRUITING
Des Moines
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Idaho
St. Luke's Boise Medical Center
RECRUITING
Boise
Illinois
Evanston Hospital
RECRUITING
Evanston
Midwest Cardiovascular Institute
RECRUITING
Naperville
Advocate Christ Medical Center
RECRUITING
Oak Lawn
Indiana
Community Heart and Vascular Hospita
RECRUITING
Indianapolis
Kansas
University of Kansas
RECRUITING
Kansas City
Kentucky
Baptist Health Lexington
RECRUITING
Lexington
Norton Hospital
RECRUITING
Louisville
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Charlton Memorial
RECRUITING
Fall River
University of Massachusetts Memorial Medical Center
RECRUITING
Worcester
Michigan
St. Joseph Mercy Hospital
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Corewell Health
RECRUITING
Grand Rapids
Minnesota
M Health Fairview St John's Hospital
RECRUITING
Maplewood
Mayo Clinic Foundation
RECRUITING
Rochester
Centracare Heart and Vascular Center
RECRUITING
Saint Cloud
Missouri
St. Luke's Hospital of Kansas City
RECRUITING
Kansas City
St. Luke's Hospital
RECRUITING
St Louis
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Mississippi Medical Center
RECRUITING
Tupelo
North Carolina
Carolinas Medical Center
RECRUITING
Charlotte
Novant Health Presbyterian Medical Center
RECRUITING
Charlotte
Rex Hospital
RECRUITING
Raleigh
Wake Medical Center
RECRUITING
Raleigh
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Cooper Hospital - University Medical Center
RECRUITING
Camden
Virtua Health
RECRUITING
Marlton
Valley Hospital
RECRUITING
Paramus
New Mexico
Lovelace Medical Center
RECRUITING
Albuquerque
New York
Northwell Health
RECRUITING
Bay Shore
Kaleida Health
RECRUITING
Buffalo
Mount Sinai Medical Center
RECRUITING
New York
New York University Medical Center
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Bethesda North Hospital-Hospital
RECRUITING
Cincinnati
Cleveland Clinic Hospital
RECRUITING
Cleveland
University Hospitals of Cleveland
RECRUITING
Cleveland
Ohio State University Medical Center
RECRUITING
Columbus
Oregon
Legacy Emanuel Hospital & Health Center
RECRUITING
Portland
Pennsylvania
Pinnacle Health at Harrisburg Hospital
RECRUITING
Harrisburg
South Carolina
Trident Medical Center
RECRUITING
Charleston
Prisma Health
RECRUITING
Columbia
Tennessee
Stern Cardiovascular Foundation
RECRUITING
Germantown
St. Thomas Heart
RECRUITING
Nashville
Texas
Texas Cardiac Arrhythmia Research
RECRUITING
Austin
Memorial Hermann Memorial City Medical Center
RECRUITING
Houston
Orion Medical
RECRUITING
Houston
Methodist Hospital
RECRUITING
San Antonio
Christus Trinity Mother Frances Health System-Hospital
RECRUITING
Tyler
Utah
St. Mark's Hospital
RECRUITING
Salt Lake City
Virginia
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Chippenham & Johnston-Willis Hospital
RECRUITING
Richmond
Carilion Roanoke Memorial Hospital
RECRUITING
Roanoke
Washington
Overlake Hospital Medical Center
RECRUITING
Bellevue
University of Washington Medical Center
RECRUITING
Seattle
Wisconsin
Bellin Health
RECRUITING
Green Bay
Froedtert Memorial Lutheran Hospital
RECRUITING
Milwaukee
West Virginia
Monongalia General Hospital
RECRUITING
Morgantown
Contact Information
Primary
Holly Burtch
holly.burtch@bsci.com
1-800-CARDIAC
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-01
Participants
Target number of participants: 1857
Treatments
Experimental: Aspirin
Aspirin 81-100 mg, daily post implant for duration of the clinical trial
Experimental: 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
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation