Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Faculty of Medical Sciences in Zabrze, Medical University of Silesia, Katowice, Poland.
Silesian Centre for Heart Diseases in Zabrze, Curie-Skłodowskiej 9, Zabrze, 41‒800, Poland.
Trials. 2023 Nov 23;24(1):749. doi: 10.1186/s13063-023-07766-3.
Left atrial appendage closure (LAAC) procedures prevent cardioembolic stroke in patients with atrial fibrillation who have contraindications to oral anticoagulant medications. However, these procedures carry certain risks of peri-procedural complications. One such complication is silent brain infarcts (SBI), which can lead to cognitive impairment and mood disturbances. The implementation of mechanical neuroprotection systems during LAAC procedures may reduce the risk of SBI and associated cognitive and mood disorders.
The LAAC-SBI trial is a prospective, multicenter, randomized, and double-blind interventional study. The study aims to enroll a total of 240 patients, with 120 patients allocated to each group. The study group will evaluate the use of the Sentinel CPS during LAAC, while the control group will undergo LAAC procedures without the Sentinel CPS. The primary endpoint of the study is the number of new SBIs or stroke foci detected by diffusion-weighted magnetic resonance imaging (DW MRI). Secondary endpoints include deterioration of cognitive function, development of dementia syndrome, and occurrence of depressive disorders. These endpoints will be assessed using questionnaire tools such as the Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT), Controlled Oral Word Association Test (COWAT), and Hospital Anxiety and Depression Scale (HADS). The observational period for patients in the study is 2 years.
If the study demonstrates a favorable outcome with reduced incidence of SBI and improved cognitive and mood outcomes in patients receiving cerebral protection devices during LAAC, it will have significant implications for clinical management standards. This would support the use of neuroprotection devices not only for LAAC but also in procedures such as atrial fibrillation ablation or transcatheter mitral valve interventions, where the risk of embolic events and subsequent brain injury may also be present.
ClinicalTrials.gov NCT05369195. Registration on 11.05.2022.
左心耳封堵术（LAAC）可预防有口服抗凝药物禁忌的房颤患者心源性卒中。然而，这些手术存在一定的围手术期并发症风险。其中一种并发症是无症状性脑梗死（SBI），可导致认知障碍和情绪障碍。在 LAAC 手术中实施机械神经保护系统可能会降低 SBI 及相关认知和情绪障碍的风险。
LAAC-SBI 试验是一项前瞻性、多中心、随机、双盲的干预性研究。该研究计划纳入 240 例患者，每组 120 例。研究组将评估在 LAAC 中使用 Sentinel CPS 的效果，而对照组将在没有 Sentinel CPS 的情况下进行 LAAC 手术。该研究的主要终点是通过弥散加权磁共振成像（DW MRI）检测到的新 SBI 或卒中灶的数量。次要终点包括认知功能恶化、痴呆综合征的发展和抑郁障碍的发生。这些终点将通过蒙特利尔认知评估（MoCA）、连线测试（TMT）、词语流畅性测试（COWAT）和医院焦虑抑郁量表（HADS）等问卷工具进行评估。研究患者的观察期为 2 年。
如果该研究表明，在 LAAC 中使用脑保护装置的患者 SBI 发生率降低，认知和情绪结局改善，这将对临床管理标准产生重大影响。这将支持不仅在 LAAC 中使用神经保护装置，而且在房颤消融或经导管二尖瓣介入等程序中使用神经保护装置，因为这些程序也可能存在栓塞事件和随后的脑损伤风险。
ClinicalTrials.gov NCT05369195. 注册于 2022 年 5 月 11 日。
