This is an early feasibility study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular atrial fibrillation that cannot take, or a have a reason to seek an alternative, to anticoagulant medications.
Left atrial appendage closure (LAAC) is an approved therapy for stroke prevention in atrial fibrillation patients who are recommended for chronic oral anticoagulation therapy (OAC), but are non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants in accordance with evidence-based decision-making criteria and current scientific guidelines. The objective of this study is to evaluate the safety and effectiveness of the Laminar Left Atrial Appendage Closure System to treat patients with non-valvular atrial fibrillation who are deemed appropriate for LAAC to reduce the risk of stroke and systemic embolism. Patients will be followed for 5 years after the procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Closure of the left atrial appendage with the Laminar Left Atrial Appendage Closure System.
Tucson Medical Center
Tucson, Arizona, United States
St. Bernard's Heart & Vascular
Jonesboro, Arkansas, United States
Scripps Health
La Jolla, California, United States
Univeristy of California Davis Health
Sacramento, California, United States
Composite Adverse Events
Composite rate of all-cause mortality, stroke, systemic embolism, life threatening or major bleeding (BARC Type 3 or 5), pericardial effusion requiring drainage, device embolization, and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.
Time frame: 45 days
Composite Adverse Events
Composite rate of all-cause mortality, stroke, systemic embolism, life threatening or major bleeding (BARC Type 3 or 5), pericardial effusion requiring drainage, device embolization, and device- or procedure-related events requiring open cardiac surgery or major endovascular intervention.
Time frame: 12 months
LAA Closure Rate
Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
Time frame: 45 days
LAA Closure Rate
Rate of LAA closure defined by peri-device flow ≤ 3mm in width per TEE evaluated by independent core laboratory.
Time frame: 12 months
LAA Closure Rate
Rate of LAA closure per CCTA evaluated by independent core laboratory. Contrast patency defined as LAA density ≥100 HU or ≥25% of that of the left atrium.
Time frame: 45 days
Composite of Ischemic Stroke or System Embolism
Composite of ischemic stroke or systemic embolism.
Time frame: 12 months
Device-Related Thrombus
Rate of device-related thrombus (DRT) per CCTA evaluated by independent core laboratory.
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Cardiovascular Institute Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Time frame: 45 days
Device-Related Thrombus
Rate of DRT per TEE evaluated by independent core laboratory.
Time frame: 12 months