Insertable cardiac monitor-guided early intervention to reduce atrial fibrillation burden following catheter ablation: Study design and clinical protocol (ICM-REDUCE-AF trial).
Insertable cardiac monitor-guided early intervention to reduce atrial fibrillation burden following catheter ablation: Study design and clinical protocol (ICM-REDUCE-AF trial).
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DOI：
10.1111/anec.13043
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发表时间：
2023-03
影响因子：
1.9
通讯作者：
Goldenberg, Ilan
中科院分区：
文献类型：
--
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
经皮导管消融（CA）实现肺静脉隔离是药物难治性阵发性和持续性房颤（AF）的有效治疗方法。然而，单次房颤消融术后的复发率仍然较高。CA消融术后的常规管理大多基于临床AF复发。然而，使用可插入心脏监护仪（ICM）和CA后患者触发的移动的应用程序传输进行的连续记录现在可用于检测亚临床AF（SCAF）的早期复发。我们假设，基于个性化ICM数据的CA后早期干预可以防止促进房性心律失常发作和维持的底物进展。这是一项随机、双盲（SCAF数据）、单三级中心临床试验，其中120例药物难治性阵发性或持续性AF患者计划接受ICM CA。将随机分配至干预组（n = 60）和对照组（n = 60），干预组由基于SCAF和患者触发的移动的应用程序传输的ICM引导早期干预组成，对照组由基于ICM确认的临床AF复发的标准干预方案组成。主要终点是AF负荷，将在AF消融后15个月通过ICM进行评估。次要终点包括医疗保健利用率、功能能力和生活质量。我们相信ICM引导的早期干预将为AF消融后管理提供一种新颖的个性化方法，可显著降低AF负担、医疗利用率并改善功能能力和生活质量。这是一项随机、双盲、单三级中心临床试验，计划对120例药物难治性阵发性或持续性房颤（AF）患者使用插入式心脏监护仪（ICM）进行导管消融。将随机分配至干预组（n = 60）和对照组（n = 60），干预组包括基于亚临床AF和患者触发的移动的应用程序传输的ICM引导早期干预，对照组包括基于ICM确认的临床AF复发的标准干预方案。我们相信ICM引导的早期干预将为AF消融后管理提供一种新颖的个性化方法，可显著降低AF负担、医疗利用率并改善功能能力和生活质量。
Percutaneous catheter ablation (CA) to achieve pulmonary vein isolation is an effective treatment for drug‐refractory paroxysmal and persistent atrial fibrillation (AF). However, recurrence rates after a single AF ablation procedure remain elevated. Conventional management after CA ablation has mostly been based on clinical AF recurrence. However, continuous recordings with insertable cardiac monitors (ICMs) and patient‐triggered mobile app transmissions post‐CA can now be used to detect early recurrences of subclinical AF (SCAF). We hypothesize that early intervention following CA based on personalized ICM data can prevent the substrate progression that promotes the onset and maintenance of atrial arrhythmias. This is a randomized, double‐blind (to SCAF data), single‐tertiary center clinical trial in which 120 patients with drug‐refractory paroxysmal or persistent AF are planned to undergo CA with an ICM. Randomization will be to an intervention arm (n = 60) consisting of ICM‐guided early intervention based on SCAF and patient‐triggered mobile app transmissions versus a control arm (n = 60) consisting of a standard intervention protocol based on clinical AF recurrence validated by the ICM. Primary endpoint is AF burden, which will be assessed from ICMs at 15 months post‐AF ablation. Secondary endpoints include healthcare utilization, functional capacity, and quality of life. We believe that ICM‐guided early intervention will provide a novel, personalized approach to post‐AF ablation management that will result in a significant reduction in AF burden, healthcare utilization, and improvements in functional capacity and quality of life. This is a randomized, double‐blind, single‐tertiary center clinical trial in which 120 patients with drug‐refractory paroxysmal or persistent atrial fibrillation (AF) are planned to undergo catheter ablation with an insertable cardiac monitor (ICM). Randomization will be to an intervention arm (n = 60) consisting of ICM‐guided early intervention based on subclinical AF and patient‐triggered mobile app transmissions versus 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 will provide a novel, personalized approach to post‐AF ablation management that will result in a significant reduction in AF burden, healthcare utilization, and improvements in functional capacity and quality of life.
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影响因子：
37.8
作者：
January CT;Wann LS;Alpert JS;Calkins H;Cigarroa JE;Cleveland JC Jr;Conti JB;Ellinor PT;Ezekowitz MD;Field ME;Murray KT;Sacco RL;Stevenson WG;Tchou PJ;Tracy CM;Yancy CW;ACC/AHA Task Force Members
通讯作者：
ACC/AHA Task Force Members
影响因子：
37.8
作者：
Nanthakumar, K;Plumb, VJ;Kay, GN
通讯作者：
Kay, GN
影响因子：
120.7
作者：
Packer, Douglas L.;Mark, Daniel B.;Lee, Kerry L.
通讯作者：
Lee, Kerry L.
影响因子：
6.1
作者：
Kirchhof, Paulus;Benussi, Stefano;Zeppenfeld, Katja
通讯作者：
Zeppenfeld, Katja
DOI：
10.1161/circoutcomes.110.958165
发表时间：
2011-05-01
影响因子：
6.9
作者：
Kim, Michael H.;Johnston, Stephen S.;Schulman, Kathy L.
通讯作者：
Schulman, Kathy L.