Phase
Condition
Stroke
Cerebral Ischemia
Chest Pain
Treatment
WATCHMAN FLX Pro LAAC Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is of legal age to participate in the study.
Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillationin the absence of moderate or greater mitral stenosis or a mechanical heart valve).
Subject is clinically indicated for and is treated or attempted to be treated with aWATCHMAN FLX™ Pro device.
Subject or legal representative is able to understand and willing to provide writteninformed consent to participate in the study.
Subject is able and willing to return for required follow-up visits andexaminations.
Exclusion
Exclusion Criteria:
Subject has a documented life expectancy of less than 6 months.
Subject is currently enrolled in another investigational study, except if thesubject is participating in a mandatory governmental registry, or a purelyobservational registry with no associated treatment.
Intracardiac thrombus is present.
An atrial septal defect repair or closure device or a patent foramen ovale repair orclosure device is present.
The LAA anatomy will not accommodate a Closure Device.
The patient has known hypersensitivity to any portion of the device material or theindividual components such that the use of the WATCHMAN FLX™ Pro Device iscontraindicated.
Any of the customary contraindications for other percutaneous catheterizationprocedure (e.g., patient size too small to accommodate transesophagealechocardiography (TEE) probe or required catheters) or conditions (e.g., activeinfection, bleeding disorder) are present.
There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12inhibitor.
Subject is of childbearing potential and is, or plans to become, pregnant during thetime of the study (method of assessment per study physician's discretion).
Study Design
Connect with a study center
Grandview Medical Center/ Affinity Cardiovascular Specialists
Birmingham, Alabama 35243
United StatesSite Not Available
University of Alabama Medical Center
Birmingham, Alabama 35233
United StatesSite Not Available
Phoenix Cardiovascular Research Group
Phoenix, Arizona 85018
United StatesSite Not Available
Tucson Medical Center
Tucson, Arizona 85712
United StatesSite Not Available
Arrhythmia Research Group
Jonesboro, Arkansas 72401
United StatesSite Not Available
Scripps Memorial Hospital
La Jolla, California 92307
United StatesSite Not Available
Good Samaritan Hospital
Los Angeles, California 90017
United StatesSite Not Available
Eisenhower Medical Center
Rancho Mirage, California 92270
United StatesSite Not Available
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
United StatesSite Not Available
Los Robles Hospital & Medical Center
Thousand Oaks, California 91360
United StatesSite Not Available
UC Health Memorial Hospital Central
Colorado Springs, Colorado 80909
United StatesSite Not Available
Cardiology Associates of Fairfield County, P.C.
Norwalk, Connecticut 06851
United StatesSite Not Available
Medstar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Manatee Memorial Hospital
Bradenton, Florida 34205
United StatesSite Not Available
Ascension St. Vincent's Medical Center
Jacksonville, Florida 32204
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
Emory University
Atlanta, Georgia 30342
United StatesSite Not Available
Memorial Health University Medical Center
Savannah, Georgia 31404
United StatesSite Not Available
Straub Medical Center
Honolulu, Hawaii 96813
United StatesSite Not Available
Advocate Christ Medical Center
Oak Lawn, Illinois 60453
United StatesSite Not Available
Community Heart and Vascular Hospital
Indianapolis, Indiana 46250
United StatesSite Not Available
MercyOne Iowa Heart Center
West Des Moines, Iowa 50266
United StatesSite Not Available
University of Kansas Health System
Kansas City, Kansas 66160
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Corewell Health
Grand Rapids, Michigan 49525
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Saint Luke's Health System
Kansas City, Missouri 64111
United StatesSite Not Available
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United StatesSite Not Available
Virtua Health
Marlton, New Jersey 08053
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
Kaleida Health - Gates Vascular Institute
Buffalo, New York 14203
United StatesSite Not Available
Rochester General Hospital
Rochester, New York 14621
United StatesSite Not Available
Novant Health Heart & Vascular Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Sanger Heart and Vascular Institute-Carolinas Medical Center
Charlotte, North Carolina 28204
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
UPMC Pinnacle Health at Harrisburg Hospital
Mechanicsburg, Pennsylvania 17050
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
WellSpan York Hospital
York, Pennsylvania 17403
United StatesSite Not Available
Erlanger Health, Inc.,
Chattanooga, Tennessee 37403
United StatesSite Not Available
Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation
Germantown, Tennessee 38138
United StatesSite Not Available
Ascension Saint Thomas
Nashville, Tennessee 37203
United StatesSite Not Available
Centennial Medical Center
Nashville, Tennessee 37203
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Texas Cardiac Arrhythmia Research
Austin, Texas 78705
United StatesSite Not Available
Memorial Hermann Memorial City Medical Center
Houston, Texas 77094
United StatesSite Not Available
Methodist Hospital
San Antonio, Texas 78229
United StatesSite Not Available
Christus Trinity Mother Frances
Tyler, Texas 75701
United StatesSite Not Available
Intermountain Medical Center
Murray, Utah 84107
United StatesSite Not Available
St. Mark's Hospital
Salt Lake City, Utah 84124
United StatesSite Not Available
Inova Fairfax Hospital
Falls Church, Virginia 22042
United StatesSite Not Available
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