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SIMPLAAFY Clinical Trial
Sponsor: Boston Scientific Corporation
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.
Official title: WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1857
Start Date
2024-10-01
Completion Date
2027-01
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
WATCHMAN FLX Pro LAAC Device
WATCHMAN FLX Pro LAAC Device Implantation
Locations (87)
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