This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Banner Good Samaritan
Phoenix, Arizona, United States
Scripps Green Hospital and Clinic
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Rate of complete exclusion
To assess the rate of complete exclusion of the left atrial appendage (defined as \< 1 mm of communication between left appendage and atrium) measured by color duplex transesophageal echocardiography TEE).
Time frame: During 1 year follow-up.
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Baptist Hospital of Miami
Miami, Florida, United States
University of Kansas Hospital and Medical Center
Kansas City, Kansas, United States
Columbia University Medical Center
New York, New York, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Texas Heart Institute
Houston, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
...and 2 more locations