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Clinical Trials in Poland / NCT05369195
Recruiting Not applicable

Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion

NCT05369195 · tracked via the Priya Life Science Poland tracker
Phase
Not applicable
Started
2023-05-26
Last updated
2023-09-28

Condition(s) studied

Atrial FibrillationSilent StrokeCognitive ImpairmentDepression

Investigational drug(s) / intervention(s)

LAAC procedure with the use of transcatheter cerebral protection systemLAAC procedure without the use of transcatheter cerebral protection system

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.

LAAC procedure without the use of transcatheter cerebral protection system: Only the aortography through radial access will be done before accessing the left atrium.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego Katowice Poland Not Yet Recruiting
Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II Krakow Poland Not Yet Recruiting
I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu Poznan Poland Not Yet Recruiting
Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny Warsaw Poland Not Yet Recruiting
Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy Warsaw Poland Not Yet Recruiting
Silesian Centre for HEart Diseases in Zabrze Zabrze Poland Recruiting

More Silesian Centre for Heart Diseases trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05369195 on ClinicalTrials.gov ↗ ← All trials in Poland