Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-24 @ 1:19 PM
NCT ID:
NCT05369195
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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05369195
Study Brief:
Protocol Section:
NCT05369195