The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage in patients with atrial fibrillation on the risk of perioperative silent brain ischemia and associated cognitive impairment and depression.
Introduction: Left atrial appendage occlusion (LAAC) procedure is a method of preventing stroke in patients with atrial fibrillation who cannot use anticoagulants. The number of patients undergoing LAAC treatment tends to increase. LAAC procedures effectively reduce the number of strokes, with a significant reduction in the risk of bleeding compared to oral anticoagulants. However, although LAAC treatments alone have a low risk of perioperative stroke, some patients may experience incidents of silent brain ischemia (SBI). The distant effect of SBI may be cognitive deterioration, the onset of dementia syndromes, as well as depression. Purpose of the study: The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage (LAAC) in patients with atrial fibrillation on the risk of perioperative SBI and associated cognitive impairment and depression. Methodology: The planned study is a prospective, multicentre, randomized, and double-blind intervention trial. Neuroprotection introduced from arterial access will be used in the LAAC treatment study group. In the control group, LAAC treatments will be performed without neuroprotection. Two hundred forty patients are planned to be enrolled with indications for stroke prevention due to atrial fibrillation. The analysis will include data obtained from DW MRI images, neurological evaluation results along with NIHSS-scale scores, results of cognitive evaluation tests (MoCA, COWAT, TMT A\&B), and test of mood disorders (HADS Scale), as well as results of the EQ-5D-5L quality of life assessment questionnaire. It is planned to observe patients participating in the study for 24 months after LAAC procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
240
After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.
Only the aortography through radial access will be done before accessing the left atrium.
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego
Katowice, Poland
NOT_YET_RECRUITINGKlinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, Poland
NOT_YET_RECRUITINGI Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Change in number of silent cerebral ischemia (SBI) foci
number of SBI foci in DW MRI of the brain
Time frame: change in the period up to 24 months
Change in volume of silent cerebral ischemia (SBI) foci
volume SBI foci in DW MRI of the brain
Time frame: change in the period up to 24 months
Deterioration of cognitive functions
Montreal Cognitive Assessment (MoCA) test (scoring 0-30; cut-off value \<26)
Time frame: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Deterioration of cognitive functions
The Trail Making Test Part A and B for Dementia (TMT A\&B) - incorrect values: for part A \> 70 sec. and for part B\> 273 sec.
Time frame: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Development of dementia
diagnosis made by a specialist neurologist
Time frame: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Occurrence of depressive disorders
Hemiltona depression scale - 0 to 50 point, the higher the score, the more severe the mood disorder
Time frame: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Presence of embolic material in the filters of the neuroprotection device
Time frame: during LAAC procedure
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Poznan, Poland
Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny
Warsaw, Poland
NOT_YET_RECRUITINGKlinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy
Warsaw, Poland
NOT_YET_RECRUITINGSilesian Centre for HEart Diseases in Zabrze
Zabrze, Poland
RECRUITING