Characterization of Post Coronary Artery Bypass Grafting Atrial Fibrillation Patterns (CABG-AF):A Feasibility Study

冠状动脉搭桥术后房颤模式 (CABG-AF) 的特征：可行性研究

• 批准号: 421895250
• 负责人: Dr. Florian Herrmann
• 金额: --
• 依托单位: Herzchirurgische Klinik und Poliklinik
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2019
• 资助国家: 德国
• 起止时间: 2018-12-31 至 2021-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/421895250?language=en
• 关键词: Characterization; Post; Coronary; Artery; Bypass

According to current literature the incidence of atrial fibrillation (AF) in the early phase after coronary artery bypass graft surgery (CABG) lies at ~ 29 %. Studies which have investigated this issue fail to provide valid data due to the use of intermittent rhythm detection methods (Holter). It has previously been shown that up to 48 % of AF recurrence is not detected using such methods. We thus hypothesize that the incidence of AF is severely underestimated in this patient population. In the CABG-AF study we aim to determine the “true” AF incidence in the first 6 months after CABG using a continuous rhythm monitoring strategy (sensitivity of >96 %). Insertable Cardiac Monitors will be implanted at the end of CABG and data will be collected continuously for 6 months. The data collected will provide insights on the primary endpoint: incidence of AF, as well as further secondary endpoints such as AF burden and density. The complete CABG-AF study will include a total of 320 patients and follow these patients for up to 3 years; the current proposal aims to secure funding for a pilot study involving 25 patients with 6 months of data collection. The pilot study will take 1 year until completion and has the goal of demonstrating the feasibility of the methodology, providing preliminary results and developing study infrastructure. At the end of the CABG-AF trial we expect to provide results which will influence guidelines on rhythm management after CABG.

根据目前的文献，冠状动脉旁路移植术（CABG）后早期房颤（AF）的发生率约为29%。由于使用了间歇性心律检测方法（霍尔特），调查该问题的研究未能提供有效数据。此前已证明，使用此类方法无法检测到高达48%的AF复发。因此，我们假设在该患者人群中AF的发生率被严重低估。在CABG-AF研究中，我们的目标是使用连续心律监测策略（灵敏度> 96%）确定CABG后前6个月的“真实”AF发生率。植入式心脏瓣膜将在CABG结束时植入，并将连续收集6个月的数据。收集的数据将提供关于主要终点（AF发生率）以及其他次要终点（如AF负荷和密度）的见解。完整的CABG-AF研究将包括总共320名患者，并对这些患者进行长达3年的随访;目前的提案旨在为涉及25名患者的试点研究提供资金，并进行6个月的数据收集。试点研究将历时一年完成，其目标是展示方法的可行性，提供初步结果并发展研究基础设施。在CABG-AF试验结束时，我们希望提供的结果将影响CABG后心律管理的指南。