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

Annals of noninvasive electrocardiology: the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc

article

Sinan S. Tankut¹  David T. Huang¹  Wojciech Zareba²  Mehmet K. Aktas¹  Spencer Z. Rosero¹  Jonathan Steinberg²  Jennifer Henchen¹  Valentina Kutyifa¹  Robert L. Strawderman²  Ilan Goldenberg² 

[1] Division of Cardiology, University of Rochester Medical Center;Clinical Cardiovascular Research Center, University of Rochester Medical Center;Summit Medical Group

关键词: atrial fibrillation;    catheter ablation;    insertable cardiac monitor;    remote monitoring;   

DOI  :  10.1111/anec.13043

来源: Wiley

【 摘 要 】

BackgroundPercutaneous 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. MethodsThis 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. ConclusionWe 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.

【 授权许可】

Unknown