ClinicalTrials.gov record
SIMPLAAFY Clinical Trial
ClinicalTrials.gov ID: NCT06521463
Public ClinicalTrials.gov record NCT06521463. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06521463
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,857 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2024 (Actual)
- Primary completion
- Jul 7, 2026 (Actual)
- Completion
- Jan 2027 (Estimated)
- Last update posted
- Oct 13, 2026
2024 – 2027
United States locations
- U.S. sites
- 86
- U.S. states
- 37
- U.S. cities
- 81
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | — |
| Grandview Medical Center | Birmingham | Alabama | 35243 | — |
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | 85018 | — |
| HonorHealth Heart Group - Shea | Scottsdale | Arizona | 85258 | — |
| PIMA Heart and Vascular | Tucson | Arizona | 85712 | — |
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | — |
| Mills Peninsula Health Services | Burlingame | California | 94010 | — |
| John Muir Medical Center | Concord | California | 94520 | — |
| Scripps Memorial Hospital | La Jolla | California | 92037 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| St. John's Health Center | Los Angeles | California | 90404 | — |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | — |
| Los Robles Hospital & Medical Center | Thousand Oaks | California | 91360 | — |
| Cardiology Associates Medical Group | Ventura | California | 93003 | — |
| Colorado Heart and Vascular PC | Lakewood | Colorado | 80401 | — |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Washington Hospital | Washington D.C. | District of Columbia | 20010 | — |
| Baptist Medical Center | Jacksonville | Florida | 32207 | — |
| Naples Community Hospital | Naples | Florida | 34102 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Georgia Arrhythmia Consultants | Macon | Georgia | 31201 | — |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31405 | — |
| Straub Medical Center | Honolulu | Hawaii | 96813 | — |
| St. Luke's Boise Medical Center | Boise | Idaho | 83712 | — |
| Kootenai Medical Center | Coeur d'Alene | Idaho | 83814 | — |
| Evanston Hospital | Evanston | Illinois | 60201 | — |
| Midwest Cardiovascular Institute | Naperville | Illinois | 60540 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| Community Heart and Vascular Hospita | Indianapolis | Indiana | 46250 | — |
| Mercy Hospital Medical Center | Des Moines | Iowa | 50266 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas | Kansas City | Kansas | 66160 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Norton Hospital | Louisville | Kentucky | 40202 | — |
| Charlton Memorial | Fall River | Massachusetts | 02720 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Corewell Health | Grand Rapids | Michigan | 49503 | — |
| M Health Fairview St John's Hospital | Maplewood | Minnesota | 55109 | — |
| Mayo Clinic Foundation | Rochester | Minnesota | 55902 | — |
| Centracare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| St. Luke's Hospital | St Louis | Missouri | 63141 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Cooper Hospital - University Medical Center | Camden | New Jersey | 08103 | — |
| Virtua Health | Marlton | New Jersey | 08053 | — |
| Valley Hospital | Paramus | New Jersey | 07652 | — |
| Lovelace Medical Center | Albuquerque | New Mexico | 87102 | — |
| Northwell Health | Bay Shore | New York | 11706 | — |
| Kaleida Health | Buffalo | New York | 14203 | — |
| New York University Medical Center | New York | New York | 10016 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Rex Hospital | Raleigh | North Carolina | 27607 | — |
| Wake Medical Center | Raleigh | North Carolina | 27610 | — |
| Bethesda North Hospital-Hospital | Cincinnati | Ohio | 45242 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Legacy Emanuel Hospital & Health Center | Portland | Oregon | 97227 | — |
| Pinnacle Health at Harrisburg Hospital | Harrisburg | Pennsylvania | 17101 | — |
| Trident Medical Center | Charleston | South Carolina | 29406 | — |
| Prisma Health | Columbia | South Carolina | 29203 | — |
| MUSC Health Columbia Medical Center Downtown | Columbia | South Carolina | 29204 | — |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | — |
| St. Thomas Heart | Nashville | Tennessee | 37203 | — |
| Texas Cardiac Arrhythmia Research | Austin | Texas | 78705 | — |
| Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | — |
| Orion Medical | Houston | Texas | 77034 | — |
| Methodist Hospital | San Antonio | Texas | 78229 | — |
| Christus Trinity Mother Frances Health System-Hospital | Tyler | Texas | 75702 | — |
| St. Mark's Hospital | Salt Lake City | Utah | 84124 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Chippenham & Johnston-Willis Hospital | Richmond | Virginia | 23235 | — |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | — |
| Overlake Hospital Medical Center | Bellevue | Washington | 98004 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| Monongalia General Hospital | Morgantown | West Virginia | 26505 | — |
| Bellin Health | Green Bay | Wisconsin | 54305 | — |
| Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06521463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06521463 live on ClinicalTrials.gov.