The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy. Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure. All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge. Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Implantation of the SEPIOLA device into the left atrial appendage.
Israeli-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
COMPLETEDTbilisi Heart and Vascular Clinic
Tbilisi, Georgia
COMPLETEDVilnius university hospital Santaros Klinikos
Vilnius, Lithuania
RECRUITINGUniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
RECRUITINGEzgu Niyat
Tashkent, Uzbekistan
RECRUITINGSEPIOLA System Safety
Device and Investigational Procedure Related Serious Adverse Events (SAE)
Time frame: 7 days, 45 days and 6 months post procedure
Device success
Confirmation of functional LAA closure
Time frame: 45 days
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