Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion

Depression Clinical Trial

— LAAC-SBI  

Official title:

Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369195
• Other study ID #: LAAC-SBI ver. 3
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: September 2026

Study information

• Verified date: March 2023
• Source: Silesian Centre for Heart Diseases
• Contact: Witold A Streb, Ph.D.
• Phone: 0048322713414
• Email: w.streb[@]sccs.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Introduction: Left atrial appendage occlusion (LAAC) procedure is a method of preventing stroke in patients with atrial fibrillation who cannot use anticoagulants. The number of patients undergoing LAAC treatment tends to increase. LAAC procedures effectively reduce the number of strokes, with a significant reduction in the risk of bleeding compared to oral anticoagulants. However, although LAAC treatments alone have a low risk of perioperative stroke, some patients may experience incidents of silent brain ischemia (SBI). The distant effect of SBI may be cognitive deterioration, the onset of dementia syndromes, as well as depression.

Purpose of the study: The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage (LAAC) in patients with atrial fibrillation on the risk of perioperative SBI and associated cognitive impairment and depression.

Methodology: The planned study is a prospective, multicentre, randomized, and double-blind intervention trial. Neuroprotection introduced from arterial access will be used in the LAAC treatment study group. In the control group, LAAC treatments will be performed without neuroprotection. Two hundred forty patients are planned to be enrolled with indications for stroke prevention due to atrial fibrillation. The analysis will include data obtained from DW MRI images, neurological evaluation results along with NIHSS-scale scores, results of cognitive evaluation tests (MoCA, COWAT, TMT A&B), and test of mood disorders (HADS Scale), as well as results of the EQ-5D-5L quality of life assessment questionnaire. It is planned to observe patients participating in the study for 24 months after LAAC procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cognitive Dysfunction
• Cognitive Impairment
• Depression
• Silent Stroke

Intervention

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

Locations

Country	Name	City	State
Poland	Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwesryeteu Medycznego	Katowice
Poland	Klinika Chorób Serca i Naczyn, Krakowski Szpital Specjalistyczny im. Jana Pawla II	Kraków
Poland	I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Swiecickiego UM w Poznaniu	Poznan
Poland	Klinika Choroby Wiencowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy	Warszawa
Poland	Klinika Kardiologii i Chorób Wewnetrznych, Wojskowy Instytut Medyczny	Warszawa
Poland	Silesian Centre for HEart Diseases in Zabrze	Zabrze

Sponsors (4)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases	Biostat Sp. z o.o., Leszek Giec Upper-Silesian Medical Centre, Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of silent cerebral ischemia (SBI) foci	number of SBI foci in DW MRI of the brain	change in the period up to 24 months
Primary	Change in volume of silent cerebral ischemia (SBI) foci	volume SBI foci in DW MRI of the brain	change in the period up to 24 months
Secondary	Deterioration of cognitive functions	Montreal Cognitive Assessment (MoCA) test (scoring 0-30; cut-off value <26)	prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Secondary	Deterioration of cognitive functions	The Trail Making Test Part A and B for Dementia (TMT A&B) - incorrect values: for part A > 70 sec. and for part B> 273 sec.	prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Secondary	Development of dementia	diagnosis made by a specialist neurologist	prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Secondary	Occurrence of depressive disorders	Hemiltona depression scale - 0 to 50 point, the higher the score, the more severe the mood disorder	prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months
Secondary	Presence of embolic material in the filters of the neuroprotection device		during LAAC procedure