Recruiting
Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
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.
ClinicalTrials.gov IDNCT05369195
PhaseNA
Enrollment240
SponsorSilesian Centre for Heart Diseases
Age18 Years
SexALL
Conditions studied
Atrial Fibrillation, Silent Stroke, Cognitive Impairment, Depression
About this study
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.
Interventions
- Procedure: LAAC procedure with the use of transcatheter cerebral protection system — After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.
- Procedure: LAAC procedure without the use of transcatheter cerebral protection system — Only the aortography through radial access will be done before accessing the left atrium.
Primary outcomes
- Change in number of silent cerebral ischemia (SBI) foci (change in the period up to 24 months)
- Change in volume of silent cerebral ischemia (SBI) foci (change in the period up to 24 months)
Eligibility information
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 or aneurysms at the exit of the LCCA or the brachiocephalic trunk from the aorta and up to 3 cm above
13. Advancement of vascular changes in DW MRI of the head, grade 3 on the Fazekas scale
14. Presence of a thrombus or tumours of a different nature in the left atrium or its ear
15. Presence of a thrombus in the left ventricle
16. Left atrial appendage anatomy preventing the use of occluders to close the left atrium appendage
17. The presence of mechanical heart valve prostheses
18. The state after the operative closure of the defect in the atrial septum
19. Condition after closing the defect in the interatrial septum with the use of occluders
20. Active infective endocarditis
21. Presence of devices and prostheses that prevent the performance of MRI (pacemakers, clips in the CNS)
22. Status after oesophagal surgery
23. Esophageal diverticula
24. Esophageal varices\> grade 3
25. Allergic to contrast agents
26. A contraindication to use antiplatelet drugs
27. Diagnosis of neoplastic disease with estimated survival beyond 1 year
28. Clininally evident hypothyroidism and hyperthyroidism
29. Klaustrofobia
30. Pregnancy
31. AIDS
32. Participation in other drug research studies
33. The presence of circumstances or any medical condition the Investigator considers problematic for subject inclusion, or test results that may couse problems to provide reliable, acurate to interpretation results
Study locations
- Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego, Katowice, 40-635 Poland
- Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II, Krakow, 31-202 Poland
- I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu, Poznan, 61-848 Poland
- Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny, Warsaw, 04-141 Poland
- Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy, Warsaw, 04-625 Poland
- Silesian Centre for HEart Diseases in Zabrze, Zabrze, 41-800 Poland
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.