The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are eligible for long-term anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
458
Left atrial appendage closure with WATCHMAN FLX
Number of Participants With a Safety Event
The occurrence of one of the following events : all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are captured as adverse events (AEs), and are excluded from this endpoint.
Time frame: events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later
Number of Participants With Effective LAA Closure
The rate of effective LAA closure, defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE at 12 months.
Time frame: 12-months
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Grandview Medical Center
Birmingham, Alabama, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Nair Research, LLC
Jonesboro, Arkansas, United States
Scripps Green
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sharpe Chula Vista Medical Center
San Diego, California, United States
St. John's Hospital / Pacific Heart
Santa Monica, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
...and 19 more locations