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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05809596
Other study ID # s2504
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 3, 2023
Est. completion date June 30, 2025

Study information

Verified date June 2024
Source Boston Scientific Corporation
Contact Angela Schutt
Phone 1-800-CARDIAC
Email angela.schutt@bsci.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 30, 2025
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject is of legal age to participate in the study. - 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 has a documented life expectancy of less than 6 months. - 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).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
WATCHMAN FLX Pro LAAC Device
Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Texas Cardiac Arrhythmia Research Austin Texas
United States Grandview Medical Center/ Affinity Cardiovascular Specialists Birmingham Alabama
United States University of Alabama Medical Center Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Manatee Memorial Hospital Bradenton Florida
United States Montefiore Medical Center Bronx New York
United States Kaleida Health - Gates Vascular Institute Buffalo 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 Erlanger Health, Inc., Chattanooga Tennessee
United States Cleveland Clinic Cleveland Ohio
United States UC Health Memorial Hospital Central Colorado Springs Colorado
United States Inova Fairfax Hospital Falls Church Virginia
United States Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation Germantown Tennessee
United States Corewell Health Grand Rapids Michigan
United States Straub Medical Center Honolulu Hawaii
United States Memorial Hermann Memorial City Medical Center Houston Texas
United States Community Heart and Vascular Hospital Indianapolis Indiana
United States Ascension St. Vincent's Medical Center Jacksonville Florida
United States Arrhythmia Research Group Jonesboro Arkansas
United States Saint Luke's Health System Kansas City Missouri
United States University of Kansas Health System Kansas City Kansas
United States Scripps Memorial Hospital La Jolla California
United States Good Samaritan Hospital Los Angeles California
United States Virtua Health Marlton New Jersey
United States UPMC Pinnacle Health at Harrisburg Hospital Mechanicsburg Pennsylvania
United States Intermountain Medical Center Murray Utah
United States Ascension Saint Thomas Nashville Tennessee
United States Centennial Medical Center Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Cardiology Associates of Fairfield County, P.C. Norwalk Connecticut
United States Advocate Christ Medical Center Oak Lawn Illinois
United States Nebraska Methodist Hospital Omaha Nebraska
United States Phoenix Cardiovascular Research Group Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Eisenhower Medical Center Rancho Mirage California
United States Mayo Clinic Rochester Minnesota
United States Rochester General Hospital Rochester New York
United States St. Mark's Hospital Salt Lake City Utah
United States Methodist Hospital San Antonio Texas
United States Santa Barbara Cottage Hospital Santa Barbara California
United States Sarasota Memorial Hospital Sarasota Florida
United States Memorial Health University Medical Center Savannah Georgia
United States Los Robles Hospital & Medical Center Thousand Oaks California
United States Tucson Medical Center Tucson Arizona
United States Christus Trinity Mother Frances Tyler Texas
United States Medstar Washington Hospital Center Washington District of Columbia
United States MercyOne Iowa Heart Center West Des Moines Iowa
United States WellSpan York Hospital York Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of leak (>5 mm) for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than the rate of leak (> 5mm) of the performance goal. Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset. 45 days
Primary The composite rate of all-cause mortality, all stroke, systemic embolism, and major bleeding for the WATCHMAN FLX™ Pro Primary Analysis Subset is less than a performance goal. Primary Analysis will be conducted on the initial 500 enrolled subjects which make up the Primary Analysis Subset. 6 months
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