Study Results
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View full resultsBasic Information
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COMPLETED
NA
949 participants
INTERVENTIONAL
2023-10-03
2025-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Device Group
WATCHMAN FLX Pro LAAC Device Implantation
WATCHMAN FLX Pro LAAC Device
Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device
Interventions
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WATCHMAN FLX Pro LAAC Device
Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in 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 a WATCHMAN FLX™ Pro device.
* Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
* Subject is able and willing to return for required follow-up visits and examinations.
Exclusion Criteria
* Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
* Intracardiac thrombus is present.
* An atrial septal defect repair or closure device or a patent foramen ovale repair or closure 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 the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated.
* Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present.
* There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor.
* Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mohamed Kanj, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Oluseun Alli, MD
Role: PRINCIPAL_INVESTIGATOR
Novant Health Heart & Vascular Institute
Locations
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Methodist Hospital
San Antonio, Texas, United States
University of Alabama Medical Center
Birmingham, Alabama, United States
Grandview Medical Center/ Affinity Cardiovascular Specialists
Birmingham, Alabama, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Scripps Memorial Hospital
La Jolla, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
UC Health Memorial Hospital Central
Colorado Springs, Colorado, United States
Cardiology Associates of Fairfield County, P.C.
Norwalk, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Straub Medical Center
Honolulu, Hawaii, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Community Heart and Vascular Hospital
Indianapolis, Indiana, United States
University of Kansas Health System
Kansas City, Kansas, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Corewell Health
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Luke's Health System
Kansas City, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Virtua Health
Marlton, New Jersey, United States
Kaleida Health - Gates Vascular Institute
Buffalo, New York, United States
Rochester General Hospital
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Novant Health Heart & Vascular Institute
Charlotte, North Carolina, United States
Sanger Heart and Vascular Institute-Carolinas Medical Center
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Pinnacle Health at Harrisburg Hospital
Mechanicsburg, Pennsylvania, United States
WellSpan York Hospital
York, Pennsylvania, United States
Erlanger Health, Inc.,
Chattanooga, Tennessee, United States
Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Ascension Saint Thomas
Nashville, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States
Christus Trinity Mother Frances
Tyler, Texas, United States
St. Mark's Hospital
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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s2504
Identifier Type: -
Identifier Source: org_study_id
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