Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM-REDUCE-AF Trial)

可插入心脏监护仪引导的早期干预以减少导管消融后心房颤动的负担（ICM-REDUCE-AF 试验）

• 批准号: 10202853
• 负责人: Ilan Goldenberg
• 金额: $ 54.11万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10202853
• 关键词: Ablation; Activities of Daily Living; Anti-Arrhythmia Agents; Arrhythmia; Atrial Fibrillation; Blinded; Cardiac; Cardiac ablation; Cardiopulmonary; Clinical; Clinical Trials; Data; Data Coordinating Center; Detection; Double-Blind Method; Drug usage; Early Diagnosis; Early Intervention; Electric Countershock; Emergency department visit; Exercise Test; Gold; Heart Atrium; Hospitalization; Intervention; Maintenance; Measures; Medical; Medical center; Monitor; Office Visits; Patients; Percutaneous Catheter Ablation; Pharmaceutical Preparations; Physicians; Population; Procedures; Protocols documentation; Pulmonary veins; Quality of life; Questionnaires; Randomized; Recurrence; Refractory; Schedule; Symptoms; Testing; Translating; Treatment Protocols; Universities; adjudicate; arm; base; clinical center; clinical development; experience; follow-up; health care service utilization; improved; improved outcome; individual response; mobile application; novel; patient subsets; personalized approach; prevent; primary endpoint; standard care; success; transmission process; treatment arm; treatment strategy

Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM-REDUCE-AF Trial) PI: Ilan Goldenberg, MD, University of Rochester Medical Center, Rochester, NY Percutaneous catheter ablation (CA) to achieve pulmonary vein electrical isolation is an effective and recommended treatment for drug-refractory paroxysmal and persistent atrial fibrillation (AF). Nevertheless, recurrence rates after a single AF ablation procedure are in the range of 30%-50%. Accordingly, more measures are needed to improve success rates following CA of AF. To date, conventional management after CA ablation has mostly been based on intervention for clinical AF recurrence. Continuous recording with insertable cardiac monitors (ICMs) can now be used to detect early recurrences of subclinical AF (SCAF) and patients-triggered mobile app transmissions post ablation. We hypothesize that early intervention following CA can prevent substrate progression that promotes the onset and maintenance of atrial arrhythmias. We therefore propose a randomized, double-blind (to SCAF data), single center, clinical trial in which 120 patients with drug-refractory paroxysmal AF or persistent AF planned to undergo CA with an ICM, will be randomized to: an intervention arm (n=60) consisting of ICM-guided early intervention based on SCAF and patient-triggered mobile app transmissions vs. a control arm (n=60) consisting of a standard intervention protocol based on clinical AF recurrence validated by the ICM. We believe that ICM-guided early intervention management provides a novel personalized approach and a paradigm shift in post-AF ablation management that will result in a significant reduction in AF burden and healthcare utilization in this expanding population, with corresponding improvements in functional capacity and quality of life, compared with conventional follow-up after AF ablation. In the proposed clinical trial, Aim 1 is to evaluate whether ICM-guided early intervention based on SCAF detection and symptom-triggered mobile app transmissions will be associated with a significant reduction in AF burden following CA for AF compared with the standard strategy of treatment upon the development of clinical AF recurrence. AF burden will be assessed from ICMs at 15 months post-AF ablation (excluding the 3-month blanking period). Aim 2 is to evaluate whether ICM-guided early intervention management will be associated with a reduction in in healthcare utilization (defined as unplanned hospitalizations, emergency department visits, cardioversions, and unplanned office visits) compared with a conventional management strategy. Aim 3 is to evaluate whether ICM-guided early intervention management will be associated with improvement in functional capacity and quality of life compared with a conventional management strategy following CA for AF.

可插入式心脏监护仪引导早期干预减轻术后心房颤动负荷 导管消融(ICM-REDUTE-AF试验) PI：伊兰·戈登伯格，医学博士，罗切斯特大学医学中心，罗切斯特，纽约 经皮导管消融(CA)实现肺静脉电隔离是一种有效而有效的方法 推荐用于药物难治性阵发性和持续性房颤(房颤)。不过， 单次房颤消融后复发率在30%-50%之间。相应地，采取更多措施 需要提高房颤CA术后的成功率。 到目前为止，CA消融后的常规治疗大多是基于临床干预 房颤复发。使用可插入式心脏监护仪(ICM)的连续记录现在可以用于早期检测 消融后亚临床房颤(SCAF)和患者触发的移动APP传输的复发。我们 假设CA后的早期干预可以防止促进发病的底物进展和 房性心律失常的维持。因此，我们提出了一种随机、双盲(对SCAF数据)、单 中心，120名药物难治性阵发性房颤或持续性房颤患者计划接受 有ICM的CA将被随机分为：干预组(n=60)，由ICM引导的早期干预组成 基于SCAF和患者触发的移动应用传输与控制臂(n=60)的对比 ICM验证了基于临床房颤复发的干预方案。我们认为，ICM引导的早期 介入治疗为房颤消融后的治疗提供了一种新的个性化方法和范式转换 管理将显著降低房颤负担和医疗保健使用率 与人口相比，人口的功能能力和生活质量得到相应改善 房颤消融后常规随访。 在拟议的临床试验中，目标1是评估ICM引导的基于SCAF的早期干预 检测和症状触发的移动应用传输将与房颤的显著减少相关 房颤患者CA术后负荷与标准治疗策略的临床对比研究 房颤复发。房颤负荷将在房颤消融后15个月(不包括3个月)由ICM评估 消隐时间段)。目标2是评估ICM引导的早期干预管理是否会与 随着医疗保健利用率的降低(定义为计划外住院、急诊科就诊、 心脏复律和计划外办公室访问)与传统的管理策略相比。目标3是 评估ICM引导的早期干预管理是否与功能改善相关 能力和生活质量与房颤CA后的传统管理策略进行比较。

项目成果

Insertable cardiac monitor-guided early intervention to reduce atrial fibrillation burden following catheter ablation: Study design and clinical protocol (ICM-REDUCE-AF trial).

• DOI: 10.1111/anec.13043
• 发表时间: 2023-03
• 期刊: ANNALS OF NONINVASIVE ELECTROCARDIOLOGY
• 影响因子: 1.9
• 作者: Tankut, Sinan S.;Huang, David T.;Zareba, Wojciech;Aktas, Mehmet K.;Rosero, Spencer Z.;Steinberg, Jonathan;Henchen, Jennifer;Kutyifa, Valentina;Strawderman, Robert L.;Goldenberg, Ilan
• 通讯作者: Goldenberg, Ilan