Neuroprotection during left atrial appendage occlusion for atrial fibrillation patients
Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation
This study is testing if using a protective treatment during a heart procedure can help prevent brain damage and improve mental health in patients with atrial fibrillation who can't take blood thinners.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Silesian Centre for Heart Diseases Academic / other |
| Locations | 6 sites (Katowice and 5 other locations) |
| Trial ID | NCT05369195 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of neuroprotection during the transcatheter left atrial appendage occlusion (LAAC) procedure in patients with atrial fibrillation. It aims to determine whether the use of neuroprotection can reduce the risk of perioperative silent brain ischemia and its associated cognitive impairment and depression. The study is a prospective, multicenter, randomized, and double-blind trial involving 240 patients who are at risk for stroke and cannot use anticoagulants. Participants will be divided into two groups: one receiving neuroprotection during LAAC and the other undergoing the procedure without it, with outcomes assessed through MRI and cognitive evaluations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with documented atrial fibrillation and a CHA2DS2VASc stroke risk score of 2 or higher who cannot use anticoagulants.
Not a fit: Patients with serious mental illnesses, a history of ischemic stroke, or significant atherosclerosis of the cephalic arteries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of silent brain ischemia and improve cognitive outcomes for patients undergoing LAAC.
How similar studies have performed: While the use of neuroprotection in this specific context is novel, similar approaches in other studies have shown promise in reducing stroke risk and improving cognitive outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Katowice and 5 other locations
- 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)
Study contacts
- Principal investigator: Zbigniew F Kalarus, Prof. — Silesian Centre for Heart Diseases in Zabrze
- Study coordinator: Witold A Streb, Ph.D.
- Email: w.streb@sccs.pl
- Phone: 0048322713414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.