This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6,573
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Primary Effectiveness Endpoint
Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure.
Time frame: Common termination point (median follow-up for 5 years)
Primary Safety Endpoint
Occurrence of at least one of the following events assessed through 30 days post index procedure: * Pericardial effusion requiring percutaneous or surgical treatment * Major bleeding attributable to index surgical procedure * Deep sternal wound infection * Myocardial infarction
Time frame: 30 days post index procedure
Powered Secondary Effectiveness endpoint
Time to the first occurrence of ischemic stroke or systemic arterial embolism
Time frame: Common termination point (median follow-up for 5 years)
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Heart Center Research / Huntsville Hospital
Huntsville, Alabama, United States
HonorHealth Shea Scottsdale Healthcare
Scottsdale, Arizona, United States
St. Bernard's Heart & Vascular
Jonesboro, Arkansas, United States
CHI St. Vincent
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Memorial Care Long Beach Medical Center
Long Beach, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Sutter Sacramento Hospital
Sacramento, California, United States
Stanford University
Stanford, California, United States
...and 128 more locations