# Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM-REDUCE-AF Trial)

> **NIH NIH R33** · UNIVERSITY OF ROCHESTER · 2024 · $528,072

## Abstract

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.

## Key facts

- **NIH application ID:** 10908601
- **Project number:** 5R33HL153001-04
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Ilan Goldenberg
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $528,072
- **Award type:** 5
- **Project period:** 2021-07-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10908601

## Citation

> US National Institutes of Health, RePORTER application 10908601, Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation (ICM-REDUCE-AF Trial) (5R33HL153001-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10908601. Licensed CC0.

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