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| Name | Class |
|---|---|
| Leszek Giec Upper-Silesian Medical Centre | UNKNOWN |
| Medical University of Silesia | OTHER |
| Biostat Sp. z o.o. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAAC with neuroprotection | Experimental | Arm in which is used a transcatheter system to protect the cerebral circulation during the left atrial appendage closure procedures. |
|
| LAAC without neuroprotection | Placebo Comparator | Arm in which the left atrial appendage closure procedures are performed without transcatheter cerebral protection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAAC procedure with the use of transcatheter cerebral protection system | Procedure | After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Deterioration of cognitive functions |
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Inclusion Criteria:
18 Years and older
Subject able to provide signed informed consent.
Documented permanent, persistent, or paroxysmal atrial fibrillation
CHA2DS2VASc risk of stroke ≥2
At least one of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Witold A Streb, Ph.D. | Contact | 0048322713414 | w.streb@sccs.pl |
| Name | Affiliation | Role |
|---|---|---|
| Zbigniew F Kalarus, Prof. | Silesian Centre for Heart Diseases in Zabrze | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego | Not yet recruiting | Katowice | 40-635 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37996955 | Derived | Streb W, Lasek-Bal A, Mitrega K, Kowalczyk J, Podolecki T, Kowalska W, Olma A, Sobczyk A, Kalarus Z. Rationale and design of a randomized clinical trial evaluating the efficacy of mechanical neuroprotection in reducing the risk of silent brain infarcts associated with percutaneous left atrial appendage closure: study protocol for a LAAC-SBI trial. Trials. 2023 Nov 23;24(1):749. doi: 10.1186/s13063-023-07766-3. |
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In order to blind the radial artery will also be punctured in control group and an aortography will be performed. Researchers participating in the randomization of patients and in the procedure will not be included in the remaining stages of the study.
| LAAC procedure without the use of transcatheter cerebral protection system | Procedure | Only the aortography through radial access will be done before accessing the left atrium. |
|
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 |
| Development of dementia | diagnosis made by a specialist neurologist | prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months |
| 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 |
| Presence of embolic material in the filters of the neuroprotection device | during LAAC procedure |
| Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II | Not yet recruiting | Krakow | 31-202 | Poland |
|
| I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu | Not yet recruiting | Poznan | 61-848 | Poland |
|
| Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny | Not yet recruiting | Warsaw | 04-141 | Poland |
|
| Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy | Not yet recruiting | Warsaw | 04-625 | Poland |
|
| Silesian Centre for HEart Diseases in Zabrze | Recruiting | Zabrze | 41-800 | Poland |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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