Heart implant aims to ditch daily blood thinner pills for millions

NCT ID NCT04394546

Ongoing Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

Summary

This study is testing if a small device implanted in the heart (called WATCHMAN FLX) is a safe and effective alternative to taking daily blood-thinning pills for people with atrial fibrillation (AFib). The goal is to prevent strokes without the long-term risk of serious bleeding that can come with blood thinners. It will involve 3,000 participants who will be randomly assigned to receive either the implant or continue with standard blood thinner medication.

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes NO responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Locations

Aarhus University Hospital

Aarhus, 8200, Denmark
AdventHealth Orlando

Orlando, Florida, 32803, United States
Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States
Arizona Arrhythmia Research Center

Phoenix, Arizona, 85016, United States
Arrythmia Research Group

Jonesboro, Arkansas, 72401, United States
Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 52315, United States
Azienda Ospedaliera Careggi

Florence, Italy
Baptist Hospital of Miami

Miami, Florida, 33176, United States
Bay Area Cardiology Associates, P.A.

Brandon, Florida, 33511, United States
Bergan Cardiology

Omaha, Nebraska, 68124, United States
Billings Clinic

Billings, Montana, 59101, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States
CHI Franciscan Health System

Tacoma, Washington, 98405, United States
CHU Grenoble-Hopital Michallon

Grenoble, 38043, France
CHU de Charleroi

Charleroi, Belgium
Cardiologicum Hamburg Praxis Wandsbek

Hamburg, Germany
Catholic Medical Center

Manchester, New Hampshire, 03102, United States
Centennial Medical Center

Nashville, Tennessee, 37203, United States
Centracare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States
Charite, Campus Benjamin Franklin

Berlin, Germany
Charlton Memorial

Fall River, Massachusetts, 02720, United States
Chiba University Hospital

Chiba, Chiba, Japan
Christiana Hospital

Newark, Delaware, 19718, United States
Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Colorado Springs Cardiologist, P.C.

Colorado Springs, Colorado, 80923, United States
Columbia University Medical Center

New York, New York, 10032, United States
Community Hospital

Munster, Indiana, 46321, United States
Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Eisenhower Medical Center

Rancho Mirage, California, 92270, United States
El Camino Hospital

Mountain View, California, 94040, United States
Elisabeth Krankenhaus Essen

Essen, Germany
Emory University Hospital

Atlanta, Georgia, 30322, United States
Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States
Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States
Fondazione Toscana Gabriele Monasterio

Pisa, PI, 56126, Italy
Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States
Glenfield Hospital

Leicester, United Kingdom
Grandview Medical Center

Birmingham, Alabama, 35243, United States
HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States
Heart Hospital of Austin

Austin, Texas, 78756, United States
Herzzentrum Dresden GmbH

Dresden, Germany
Hopital Cardiologique de Lyon

Bron, France
Hospital Clinico Salamanca

Salamanca, Spain
Hospital de Leon

León, 24071, Spain
Hospital de la Pitie-Salpetriere

Paris, 75151, France
Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain
Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States
Institut universitaire de Cardiologie et de Pneumologie de Quebec

Québec, Canada
Instituto Clinico Humanitas

Rozzano, Italy
Iwate Medical University Hospital

Shiwa-gun, Iwate, 028-3695, Japan
John Radcliffe Hospital

Oxford, United Kingdom
Kaleida Health

Buffalo, New York, 14203, United States
Kettering Medical Center

Kettering, Ohio, 45429, United States
King Fahed Medical City- Prince Salman Cardiac Center

Riyadh, Saudi Arabia
Klinikum der Ludwig-Maximilians-Universitat

München, Germany
Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, 802-8555, Japan
Kurashiki Central Hospital

Okayama, Japan
Lahey Clinic Hospital

Burlington, Massachusetts, 01805, United States
Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States
Legacy Emanuel Hospital & Health Center

Portland, Oregon, 97227, United States
Lexington Medical Center

West Columbia, South Carolina, 29169, United States
Los Robles Hospital and Medical Center

Los Angeles, California, 91360, United States
Manatee Memorial Hospital

Bradenton, Florida, 34205, United States
Marin General Hospital

Greenbrae, California, 94904, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States
Medical University of South Carolina

Columbia, South Carolina, 29204, United States
Memorial Health University Medical Center

Savannah, Georgia, 31404, United States
Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States
Mercy General Hospital

Sacramento, California, 95819, United States
Mercy Hospital

Coon Rapids, Minnesota, 55433, United States
Mercy Hospital Medical Center

Des Moines, Iowa, 50314, United States
Methodist Le Bonheur Healthcare

Germantown, Tennessee, 38138, United States
Methodist Texsan Hospital

San Antonio, Texas, 78201-2009, United States
Mitsui Memorial Hospital

Chiyoda-ku, Tokyo, Japan
Monash Medical Centre

Clayton, Victoria, 3168, Australia
Monongalia General Hospital

Morgantown, West Virginia, 26505, United States
Mount Sinai Medical Center

New York, New York, 10029, United States
North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States
Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States
Norton Hospital

Louisville, Kentucky, 40202, United States
Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States
OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium
Ospedale Degli Infermi

Rivoli, 10098, Italy
PeaceHealth Southwest Medical

Vancouver, Washington, 98668, United States
Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States
Piedmont Hospital

Atlanta, Georgia, 30309, United States
Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, 17101, United States
Poznan University of Medical Sciences

Długa, Poznań, Poland
Providence Regional Medical Center Everett

Everett, Washington, 98201, United States
Rochester General Hospital

Rochester, New York, 14621, United States
Royal Sussex County Hospital

Brighton, United Kingdom
SANA Kliniken Oberfranken Coburg GmbH

Coburg, Germany
Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States
Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85258, United States
Scripps Memorial Hospital

La Jolla, California, 92037, United States
Shaare Zedek Medical Center

Jerusalem, Israel
Sharp Chula Vista Medical Center

Chula Vista, California, 91911, United States
Sheba Medical Center

Ramat Gan, Israel
Shonan Kamakura General Hospital

Okamoto, Japan
Sparrow Health System - Sparrow Hospital

Lansing, Michigan, 48912, United States
St. Antonius Ziekenhuis

Nieuwegein, Netherlands
St. Francis Hospital

Roslyn, New York, 11576, United States
St. John's Health Center

Santa Monica, California, 90404, United States
St. John's Hospital

Springfield, Illinois, 62701, United States
St. Katharinen Krankenhaus

Frankfurt, 60389, Germany
St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States
St. Vincent's Hospital-Sydney

Darlinghurst, New South Wales, Australia
St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States
St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

Erfurt, Germany
Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada
Swedish Medical Center

Seattle, Washington, 98122, United States
Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States
Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States
The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States
The Nebraska Medical Center

Omaha, Nebraska, 68198, United States
The Toledo Hospital

Toledo, Ohio, 43606, United States
Toho University Ohashi Medical Center

Tokyo, Japan
Toyama University Hospital

Toyama, Japan
Toyohashi Heart Center

Toyohashi, Japan
Trident Medical Center

Charleston, South Carolina, 29406, United States
Tucson Medical Center Healthcare

Tucson, Arizona, 85712, United States
Universitaetsklinikum Schleswig-Holstein

Lübeck, Germany
University Hospital Zurich

Zurich, 8091, Switzerland
University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35294-6830, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
University of Kansas Hospital

Kansas City, Kansas, 66160, United States
University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States
University of Tsukuba Hospital

Tsukuba, Japan
Vanderbilt University Medical Center

Nashville, Tennessee, 37232-7235, United States
Virginia Commonwealth University Health System

Richmond, Virginia, 23219, United States
Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Westmead Hospital

Bella Vista, Australia
William Beaumont Hospital

Royal Oak, Michigan, 48073, United States
Yale University School of Medicine

New Haven, Connecticut, 06473, United States
York Hospital

York, Pennsylvania, 17403, United States

Conditions

Explore the condition pages connected to this study.

ATRIAL FIBRILLATION BLEEDING STROKE