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: 10434168
• 负责人: Ilan Goldenberg
• 金额: $ 55.94万
• 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 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10434168
• 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.

植入式心脏导管引导的早期介入治疗减少房颤负荷 导管消融（ICM-REDUCE-AF试验） PI：Ilan Goldenberg，MD，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的， 推荐治疗药物难治性阵发性和持续性房颤（AF）。然而，尽管如此， 单次AF消融术后的复发率在30%-50%的范围内。因此，更多的措施 以提高AF CA后的成功率。 迄今为止，CA消融术后的常规管理大多基于临床干预， 房颤复发。通过可插入心脏监测器（ICM）进行连续记录， 亚临床AF（SCAF）复发和消融后患者触发的移动的应用程序传输。我们 假设CA后早期干预可以防止促进发病的底物进展， 维持房性心律失常。因此，我们提出了一个随机，双盲（SCAF数据），单 一项中心临床试验，计划对120例药物难治性阵发性AF或持续性AF患者进行 CA伴ICM，将被随机分配至：干预组（n=60），包括ICM引导的早期干预 基于SCAF和患者触发的移动的应用程序传输与由标准器械组成的对照组（n=60） 基于ICM确认的临床AF复发的干预方案。我们认为，ICM引导的早期 介入管理提供了一种新的个性化方法，并在AF消融术后实现了范式转变 管理，这将导致AF负担和医疗保健利用的显着减少，在这个扩大 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，目的1是评估基于SCAF的ICM引导的早期干预是否 检测和触发的移动的应用程序传输将与AF的显著减少相关 与标准治疗策略相比，CA治疗AF后的负担 房颤复发。将在AF消融后15个月（不包括3个月）从ICM评估AF负荷 消隐期）。目的2是评估ICM引导的早期干预管理是否与 随着医疗保健利用（定义为计划外住院，急诊室就诊， 心脏复律和计划外的办公室访问）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 容量和生活质量与传统的管理策略相比，CA AF。