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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.
This study is a prospective, randomized, open-label, triple-arm, multi-center trial. Subjects will be randomized 1:1:1 to one of the three therapy arms and remain on treatment through the end of study (12 months):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin | Experimental | Aspirin 81-100 mg, daily post implant for duration of the clinical trial |
|
| Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) | Experimental | Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) for the first 3 months daily, post implant, followed by aspirin only for the duration of the clinical trial |
|
| DAPT | Active Comparator | DAPT (aspirin 81-100 mg + clopidogrel 75 mg), for the first 6-months daily followed by aspirin only for the duration of the clinical trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WATCHMAN FLX Pro LAAC Device | Device | WATCHMAN FLX Pro LAAC Device Implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT arm | Non Inferiority | 6 months after randomization |
| Aspirin Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the Aspirin arm tested for non-inferiority compared to the DAPT arm. | Non Inferiority | 6 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Reddy, MD | Icahn School of Medicine at Mount Sinai | Study Chair |
| Saibal Kar, MD | Los Robles Health System | Principal Investigator |
| Walid Saliba, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Grandview Medical Center |
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|
| Birmingham |
| Alabama |
| 35243 |
| United States |
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | 85018 | United States |
| HonorHealth Heart Group - Shea | Scottsdale | Arizona | 85258 | United States |
| Tucson Medical Center Healthcare | Tucson | Arizona | 85712 | United States |
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | United States |
| Mills Peninsula Health Services | Burlingame | California | 94010 | United States |
| John Muir Medical Center | Concord | California | 94520 | United States |
| Scripps Memorial Hospital | La Jolla | California | 92037 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| St. John's Health Center | Los Angeles | California | 90404 | United States |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | United States |
| Los Robles Hospital & Medical Center | Thousand Oaks | California | 91360 | United States |
| Cardiology Associates Medical Group | Ventura | California | 93003 | United States |
| Colorado Heart and Vascular PC | Lakewood | Colorado | 80401 | United States |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| Washington Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| Baptist Medical Center | Jacksonville | Florida | 32207 | United States |
| Naples Community Hospital | Naples | Florida | 34102 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Georgia Arrhythmia Consultants | Macon | Georgia | 31201 | United States |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31405 | United States |
| Straub Medical Center | Honolulu | Hawaii | 96813 | United States |
| St. Luke's Boise Medical Center | Boise | Idaho | 83712 | United States |
| Kootenai Medical Center | Coeur d'Alene | Idaho | 83814 | United States |
| Evanston Hospital | Evanston | Illinois | 60201 | United States |
| Midwest Cardiovascular Institute | Naperville | Illinois | 60540 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Community Heart and Vascular Hospita | Indianapolis | Indiana | 46250 | United States |
| Mercy Hospital Medical Center | Des Moines | Iowa | 50266 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas | Kansas City | Kansas | 66160 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Norton Hospital | Louisville | Kentucky | 40202 | United States |
| Charlton Memorial | Fall River | Massachusetts | 02720 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Corewell Health | Grand Rapids | Michigan | 49503 | United States |
| M Health Fairview St John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Mayo Clinic Foundation | Rochester | Minnesota | 55902 | United States |
| Centracare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| St. Luke's Hospital | St Louis | Missouri | 63141 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Cooper Hospital - University Medical Center | Camden | New Jersey | 08103 | United States |
| Virtua Health | Marlton | New Jersey | 08053 | United States |
| Valley Hospital | Paramus | New Jersey | 07652 | United States |
| Lovelace Medical Center | Albuquerque | New Mexico | 87102 | United States |
| Northwell Health | Bay Shore | New York | 11706 | United States |
| Kaleida Health | Buffalo | New York | 14203 | United States |
| New York University Medical Center | New York | New York | 10016 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| Rex Hospital | Raleigh | North Carolina | 27607 | United States |
| Wake Medical Center | Raleigh | North Carolina | 27610 | United States |
| Bethesda North Hospital-Hospital | Cincinnati | Ohio | 45242 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Legacy Emanuel Hospital & Health Center | Portland | Oregon | 97227 | United States |
| Pinnacle Health at Harrisburg Hospital | Harrisburg | Pennsylvania | 17101 | United States |
| Trident Medical Center | Charleston | South Carolina | 29406 | United States |
| Prisma Health | Columbia | South Carolina | 29203 | United States |
| MUSC Health Columbia Medical Center Downtown | Columbia | South Carolina | 29204 | United States |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | United States |
| St. Thomas Heart | Nashville | Tennessee | 37203 | United States |
| Texas Cardiac Arrhythmia Research | Austin | Texas | 78705 | United States |
| Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | United States |
| Orion Medical | Houston | Texas | 77034 | United States |
| Methodist Hospital | San Antonio | Texas | 78229 | United States |
| Christus Trinity Mother Frances Health System-Hospital | Tyler | Texas | 75702 | United States |
| St. Mark's Hospital | Salt Lake City | Utah | 84124 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Chippenham & Johnston-Willis Hospital | Richmond | Virginia | 23235 | United States |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | United States |
| Overlake Hospital Medical Center | Bellevue | Washington | 98004 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Monongalia General Hospital | Morgantown | West Virginia | 26505 | United States |
| Bellin Health | Green Bay | Wisconsin | 54305 | United States |
| Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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