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Recruiting NCT05369195

Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion

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Trial Parameters

Condition Atrial Fibrillation
Sponsor Silesian Centre for Heart Diseases
Study Type INTERVENTIONAL
Phase N/A
Enrollment 240
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-05-26
Completion 2025-12-31
Interventions
LAAC procedure with the use of transcatheter cerebral protection systemLAAC procedure without the use of transcatheter cerebral protection system

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. 18 Years and older 2. Subject able to provide signed informed consent. 3. Documented permanent, persistent, or paroxysmal atrial fibrillation 4. CHA2DS2VASc risk of stroke ≥2 5. At least one of the following criteria: 1. Contraindications to the use of anticoagulants, 2. HSBLED bleeding risk ≥3 Exclusion Criteria: 1. Serious mental diseases, particularly: dementia syndrome of any etiology, schizophrenia,schizoaffective disorders, bipolar disorder 2. History of ischemic stroke 3. Chronic abuse of alcohol or any other psychoactive substances except for nicotine 4. long-term therapy with benzodiazepines 5. The use of antidepressants in 3 months prior inclusion. 6. Previous infections of the central nervous system, including neuroborreliosis 7. Parkinson's disease 8. Huntington's chorea 9. Creutzfeld-Jakob disease 10. Pick's disease 11. Significant atherosclerosis of the cephalic arteries (\> 70% LCCA or the brachiocephalic trunk) 12. Strictures, ectasias, dissection

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