The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.
The ASAP-TOO study is a prospective, randomized, multi-center, global investigation to establish the safety and effectiveness of the WATCHMAN Device for subjects with non-valvular atrial fibrillation who are deemed not suitable for anti-coagulation therapy to reduce the risk of stroke. Subjects will be randomized in a ratio of 2 Device to 1 Control to receive the WATCHMAN LAA closure device (Device) or the control treatment of single antiplatelet medication or no medication at the discretion of the study physician (Control). All randomized subjects will follow the protocol required tests and assessments at each scheduled follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
481
WATCHMAN LAAC Implant
Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.
Primary 7-Day Device/Procedural Safety Endpoint
The primary safety endpoint is the 7-day combined rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.
Time frame: 7 days
Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism.
The primary efficacy endpoint is the comparison of time to first event of ischemic stroke and systemic embolism.
Time frame: 5 years
Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death
The occurrence of stroke (including ischemic and/or hemorrhagic), cardiovascular death (cardiovascular and/or unexplained cause) and systemic embolism
Time frame: 5 years
Secondary Endpoint - Major Bleeding
The occurrence of major bleeding (defined as a BARC Type 3 or 5 event)
Time frame: 5 years
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Grandview Medical Center
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Arrhythmia Research Group
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Cedars - Sinai Medical Center
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...and 82 more locations