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

• Published in: Annals of noninvasive electrocardiology 2023-03, Vol.28 (2), p.e13043-n/a
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Ablation; Applications programs; Asymptomatic; atrial fibrillation; Atrial Fibrillation - diagnosis; Atrial Fibrillation - surgery; Blood clots; Cardiac arrhythmia; catheter ablation; Catheter Ablation - methods; Catheters; Clinical Protocols; Clinical trials; Contraindications; Customization; Electrocardiography; Emergency medical care; Fibrillation; Health care; Health services utilization; Heart; Hospitalization; Humans; Informed consent; insertable cardiac monitor; Intervention; Medical instruments; Mobile computing; Mortality; Original; Patients; Pulmonary Veins; Quality of Life; Questionnaires; Radiofrequency ablation; Randomization; Randomized Controlled Trials as Topic; Recurrence; remote monitoring; Substrates; Surgery; Treatment Outcome
• ISSN: 1082-720X; 1542-474X
• DOI: 10.1111/anec.13043

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. 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