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ACTIVE NOT RECRUITING
NCT06521463
NA

SIMPLAAFY Clinical Trial

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

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

Interventions

DEVICE

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