The objective of this study is to demonstrate safety and effectiveness using a percutaneous Delivery System of the Laminar Left Atrial Appendage Closure System to treat patients with NVAF to reduce the risk of thromboembolism from the left atrial appendage (LAA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
29
Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
Sanatorio Italiano Hospital
Asunción, Paraguay
Hospital de Clinicas San Lorenzo, National University
San Lorenzo, Paraguay
Freedom from device or procedure related serious adverse events
Time frame: 7 days
Confirmation of functional LAA closure as defined by residual peri-device flow ≤ 5mm per TEE
Time frame: 45 days
Absence of all-cause mortality, major bleeding, ischemic stroke, or systemic embolism
Time frame: 45 days and 6 months
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