Department of Cardiology, Nihon University Itabashi Hospital, Itabashi-ku, Tokyo, Japan
Department of Cardiology, Nihon University Itabashi Hospital, Itabashi-ku, Tokyo, Japan.
BMJ Open. 2023 Feb 15;13(2):e068894. doi: 10.1136/bmjopen-2022-068894.
Data are lacking on the extent to which patients with non-valvular atrial fibrillation (AF) who are aged ≥80 years benefit from ablation treatment. The question pertains especially to patients' postablation quality of life (QoL) and long-term clinical outcomes.
We are initiating a prospective, registry-based, multicentre observational study that will include patients aged ≥80 years with non-valvular AF who choose to undergo treatment by catheter ablation and, for comparison, such patients who do not choose to undergo ablation (either according to their physician's advice or their own preference). Study subjects are to be enrolled from 52 participant hospitals and three clinics located throughout Japan from 1 June 2022 to 31 December 2023, and each will be followed up for 1 year. The planned sample size is 660, comprising 220 ablation group patients and 440 non-ablation group patients. The primary endpoint will be the composite incidence of stroke/transient ischaemic attack (TIA) or systemic embolism (SE), another cardiovascular event, major bleeding and/or death from any cause. Other clinical events such as postablation AF recurrence, a fall or bone fracture will be recorded. We will collect standard clinical background information plus each patient's Clinical Frailty Scale score, AF-related symptoms, QoL (Five-Level Version of EQ-5D) scores, Mini-Mental State Examination (optional) score and laboratory test results, including measures of nutritional status, on entry into the study and 1 year later, and serial changes in symptoms and QoL will also be secondary endpoints. Propensity score matching will be performed to account for covariates that could affect study results.
The study conforms to the Declaration of Helsinki and the Ethical Guidelines for Clinical Studies issued by the Ministry of Health, Labour and Welfare, Japan. Results of the study will be published in one or more peer-reviewed journals.
UMIN000047023.
关于年龄≥80 岁的非瓣膜性心房颤动（AF）患者接受消融治疗获益的程度，目前相关数据有限。该问题尤其涉及到患者消融后的生活质量（QoL）和长期临床结局。
我们正在开展一项前瞻性、基于注册的、多中心观察性研究，将纳入选择导管消融治疗的年龄≥80 岁的非瓣膜性 AF 患者，并与选择不进行消融治疗的患者（根据医生的建议或个人偏好）进行比较。研究对象将于 2022 年 6 月 1 日至 2023 年 12 月 31 日从日本 52 家参与医院和 3 家诊所招募，并对每位患者随访 1 年。计划入组 660 例患者，包括 220 例消融组患者和 440 例非消融组患者。主要终点为卒中/短暂性脑缺血发作（TIA）或系统性栓塞（SE）、另一次心血管事件、大出血和/或任何原因导致的死亡的复合发生率。还将记录消融后 AF 复发、跌倒或骨折等其他临床事件。我们将收集标准临床背景信息，外加每位患者的临床虚弱量表评分、AF 相关症状、QoL（EQ-5D 五维版）评分、简易精神状态检查（可选）评分和实验室检查结果，包括营养状况的测量，在入组时和 1 年后进行，并将症状和 QoL 的变化作为次要终点。将进行倾向评分匹配以考虑可能影响研究结果的协变量。
该研究符合赫尔辛基宣言和日本厚生劳动省发布的临床研究伦理指南。研究结果将发表在一份或多份同行评议的期刊上。
UMIN000047023。
