This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.
The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
800
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Subjects receive warfarin
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100\*N events/Total patient-years)
Time frame: 5 years
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events
Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.
Time frame: 5 years
Procedure Success
Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.
Time frame: Initial implant procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Advanced Cardiac Specialists
Gilbert, Arizona, United States
Arizona Arrhythmia
Scottsdale, Arizona, United States
Foundation for Cardiovascular Medicine
La Jolla, California, United States
Los Angeles Cardiology Associates
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Cedars-Sinai Medical Center
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El Camino Hospital
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Orange County Heart
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UC Davis Medical Center
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St. John's Hospital / Pacific Heart
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Washington Hospital Center
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...and 52 more locations