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

Autor: Tankut SS; Division of Cardiology, University of Rochester Medical Center, Rochester, New York, USA., Huang DT; Division of Cardiology, University of Rochester Medical Center, Rochester, New York, USA., Zareba W; Clinical Cardiovascular Research Center, University of Rochester Medical Center, Rochester, New York, USA., Aktas MK; Division of Cardiology, University of Rochester Medical Center, Rochester, New York, USA., Rosero SZ; Division of Cardiology, University of Rochester Medical Center, Rochester, New York, USA., Steinberg J; Clinical Cardiovascular Research Center, University of Rochester Medical Center, Rochester, New York, USA.; Summit Medical Group, Short Hills, New Jersey, USA., Henchen J; Division of Cardiology, University of Rochester Medical Center, Rochester, New York, USA., Kutyifa V; Division of Cardiology, University of Rochester Medical Center, Rochester, New York, USA., Strawderman RL; Clinical Cardiovascular Research Center, University of Rochester Medical Center, Rochester, New York, USA., Goldenberg I; Clinical Cardiovascular Research Center, University of Rochester Medical Center, Rochester, New York, USA.
Jazyk: angličtina
Zdroj: Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc [Ann Noninvasive Electrocardiol] 2023 Mar; Vol. 28 (2), pp. e13043. Date of Electronic Publication: 2023 Jan 31.
DOI: 10.1111/anec.13043
Abstrakt: Background: 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.
Methods: 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.
Conclusion: 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.
(© 2023 The Authors. Annals of Noninvasive Electrocardiology published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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