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.

可插入心脏监测仪引导的早期干预，以减轻心房颤动负担 导管消融（ICM-REDUCE-AF试验） PI：纽约州罗切斯特的罗切斯特医学中心医学博士Ilan Goldenberg，医学博士 经皮导管消融（CA）以实现肺静脉电分离是有效的，并且 推荐治疗药物难治性阵发性和持续性心房颤动（AF）的治疗方法。尽管如此， 单个AF消融过程后的复发率在30％-50％的范围内。因此，更多的措施 需要提高AF CA之后的成功率。 迄今为止，CA消融后的常规管理主要基于临床干预 AF复发。现在可以使用可插入心脏监视器（ICM）的连续记录来提早检测 消融后，亚临床AF（SCAF）和患者触发的移动应用传输的复发。我们 假设CA之后的早期干预可以防止底物进展，从而促进发作和 维持心律不齐。因此，我们提出了一个随机的双盲（SCAF数据） 中心，临床试验，其中有120例药物难治性阵发性AF或持续性AF的患者计划接受 带有ICM的CA将随机分配给：由ICM引导的早期干预组成的干预组（n = 60） 基于SCAF和由患者触发的移动应用传输与由标准组成的控制臂（n = 60） 基于ICM验证的临床AF复发的干预方案。我们相信ICM早期引入 干预管理提供了一种新颖的个性化方法和AF后消融后的范式转变 在这种扩展的情况下，将大大减少AF负担和医疗保健利用的管理 人口，功能能力和生活质量的相应改善，与 AF消融后的常规随访。 在拟议的临床试验中，目标1是评估ICM是否基于SCAF的早期干预 检测和症状触发的移动应用传输将与AF的大幅减少有关 与临床发展后的标准治疗策略相比，AF的负担遵循CA AF复发。 AF负担将在AF-AFRation后15个月从ICMS进行评估（不包括3个月 空白期）。 AIM 2是评估ICM指导的早期干预管理是否会关联 随着医疗保健利用的减少（定义为计划外住院，急诊就诊， 与传统的管理策略相比，有反转和计划外的办公室访问）。目标3是 评估ICM引导的早期干预管理是否与功能的改善有关 与AF的CA之后的常规管理策略相比，能力和生活质量。