Empirical Anatomy-Based Ablation vs Emphasize Map-Guided Substrate Ablation

Recruiting

19 years or above

All

Phase N/A

360 participants needed

1 Location

Brief description of study

This study is aimed to compare the clinical efficacy of two different catheter ablation strategies in patients with persistent atrial fibrillation.

Participants will be randomized 1:1 into either the Anatomy-based group or the Emphasize map-guided group

Anatomy-based group : Pulmonary vein isolation (PVI) using pulsed-field ablation (PFA) with a single-shot multielectrode catheter.
Emphasize map-guided group : PVI using radiofrequency (RF) ablation followed by additional EnSite X-guided pathologic substrate modification.

Participants will be followed for 1 year to compare the incidence of any atrial tachyarrhythmia and other clinical parameters between the two groups.

Detailed description of study

Pulsed-field ablation (PFA) is increasingly being adopted in clinical practice due to its advantages in shortening procedure times and reducing the incidence of complications. While the majority of PFA-related research has focused on PVI-centric strategies, recent studies have reported that posterior wall isolation (PWI) using PFA can also be performed safely. However, sufficient clinical evidence regarding the efficacy of additional ablation strategies beyond PVI in patients with persistent atrial fibrillation (AF) has yet to be established.

The Emphasize mapping system, a software feature within the EnSite X platform, is designed to simultaneously visualize Voltage maps, Peak frequency, and CFAE-related information. Unlike the individual analysis of each parameter, this integrated approach allows for a more precise identification of electrophysiologically significant pathologic substrates by evaluating the complex characteristics of electrical signals holistically. Currently, however, Emphasize-guided ablation is technically limited to the use of radiofrequency (RF) energy.

Persistent AF is characterized by complex and heterogeneous mechanisms, meaning a single, uniform ablation strategy may not yield consistent clinical outcomes across all patients. Consequently, it is hypothesized that an individualized substrate ablation strategy guided by functional mapping may be more effective than a conventional, empirical anatomy-based approach.

Therefore, this study aims to compare the clinical efficacy and safety of an empirical anatomy-based ablation strategy using PFA versus an individualized Emphasize map-guided substrate ablation strategy in patients with persistent AF.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Atrial Fibrillation (AF)
Age: 19 years or above
Gender: All

Inclusion Criteria:

Adults aged 19 years or older who have voluntarily provided written informed consent to participate in the study
Patients diagnosed with persistent atrial fibrillation (AF) who are scheduled to undergo catheter ablation for AF.

Exclusion Criteria:

History of prior catheter ablation or MAZE surgery for atrial fibrillation.
Left atrial (LA) diameter exceeding 60 mm.
Patients with end-stage renal disease (ESRD).
History of prior open-heart surgery.
Women who are pregnant, lactating, or of childbearing potential.
Heart failure corresponding to New York Heart Association (NYHA) functional class IV.
Acute coronary syndrome (ACS) experienced within the past 3 months.
Patients with terminal illness and a life expectancy of less than one year.
Any other condition that the investigator deems inappropriate for participation in the study.

Updated on 27 Jul 2026. Study ID: SMC 2026-02-103

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