Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in number of silent cerebral ischemia (SBI) foci [Срок оценки: change in the period up to 24 months]
• Change in volume of silent cerebral ischemia (SBI) foci [Срок оценки: change in the period up to 24 months]

Вторичные конечные точки (5)

• Deterioration of cognitive functions [Срок оценки: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months]
• Deterioration of cognitive functions [Срок оценки: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months]
• Development of dementia [Срок оценки: prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months]
• Occurrence of depressive disorders [Срок оценки: 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 [Срок оценки: during LAAC procedure]

Критерии участия

Критерии включения

• 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:

• Contraindications to the use of anticoagulants,
• HSBLED bleeding risk ≥3

Критерии исключения

• Serious mental diseases, particularly: dementia syndrome of any etiology, schizophrenia,schizoaffective disorders, bipolar disorder
• History of ischemic stroke
• Chronic abuse of alcohol or any other psychoactive substances except for nicotine
• long-term therapy with benzodiazepines
• The use of antidepressants in 3 months prior inclusion.
• Previous infections of the central nervous system, including neuroborreliosis
• Parkinson's disease
• Huntington's chorea
• Creutzfeld-Jakob disease
• Pick's disease
• Significant atherosclerosis of the cephalic arteries (> 70% LCCA or the brachiocephalic trunk)
• Strictures, ectasias, dissection or aneurysms at the exit of the LCCA or the brachiocephalic trunk from the aorta and up to 3 cm above
• Advancement of vascular changes in DW MRI of the head, grade 3 on the Fazekas scale
• Presence of a thrombus or tumours of a different nature in the left atrium or its ear
• Presence of a thrombus in the left ventricle
• Left atrial appendage anatomy preventing the use of occluders to close the left atrium appendage
• The presence of mechanical heart valve prostheses
• The state after the operative closure of the defect in the atrial septum
• Condition after closing the defect in the interatrial septum with the use of occluders
• Active infective endocarditis
• Presence of devices and prostheses that prevent the performance of MRI (pacemakers, clips in the CNS)
• Status after oesophagal surgery
• Esophageal diverticula
• Esophageal varices> grade 3
• Allergic to contrast agents
• A contraindication to use antiplatelet drugs
• Diagnosis of neoplastic disease with estimated survival beyond 1 year
• Clininally evident hypothyroidism and hyperthyroidism
• Klaustrofobia
• Pregnancy
• AIDS
• Participation in other drug research studies
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Польша · 6 центров

• Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego — Katowice
• Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II — Krakow
• I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpita — Poznan
• Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny — Warsaw
• Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Ste — Warsaw
• Silesian Centre for HEart Diseases in Zabrze — Zabrze

Публикации

• 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 PMID 37996955

Идентификаторы

NCT: NCT05369195 · LAAC-SBI ver. 3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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