LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
4,000
Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
Ischemic stroke or systemic embolism
The primary efficacy variable is the time from randomization to first occurrence of any of the components of the composite outcome (adjudicated) over the duration of follow-up, including: * Ischemic stroke (Strokes of undetermined etiology will be treated as ischemic stroke) * Systemic embolism
Time frame: The study duration is event-driven. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
All-cause stroke or systemic embolism
Secondary efficacy outcomes will be evaluated in a hierarchical fashion only when the primary outcome meets statistical significance in the specified order: Time from randomization to first occurrence of all-cause stroke or systemic embolism
Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
All-cause stroke, systemic embolism, or transient ischemic attack (TIA)
Time from randomization to first occurrence of all-cause stroke, systemic embolism or transient ischemic attack (TIA)
Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Montreal Cognitive Assessment (MoCA) Score
Proportion of participants with a decrease of two or more points on the MoCA score at either year 2 or end of study
Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
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Affinity Hospital dba Grandview Medical Center
Birmingham, Alabama, United States
WITHDRAWNArrhythmia Research Group
Jonesboro, Arkansas, United States
RECRUITINGMemorial Health Services
Fountain Valley, California, United States
RECRUITINGLoma Linda University Health
Loma Linda, California, United States
WITHDRAWNCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGSouthern California Permanente Medical Group
Pasadena, California, United States
RECRUITINGSutter Valley Hospitals dba Sutter Institute for Medical Research
Sacramento, California, United States
RECRUITINGChristiana Care Health Services, Inc.
Wilmington, Delaware, United States
RECRUITINGJFK Medical Center Limited Partnership d/b/a HCA Florida JFK Hospital
Atlantis, Florida, United States
WITHDRAWNSt. Vincent's Health System
Jacksonville, Florida, United States
WITHDRAWN...and 140 more locations
New disabling ischemic strokes
Time from randomization to first occurrence of disabling ischemic strokes with modified Rankin Score (mRS) \>2, measured at 90 days post-stroke
Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
Cardiovascular mortality
Time from randomization to cardiovascular mortality
Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).
All-cause mortality
Time from randomization to all-cause mortality
Time frame: Will be evaluated once primary outcome meets statistical significance. The primary analysis will be performed through study completion, once 265 primary efficacy endpoint events have occurred (an estimated average follow-up of 4 years).