Empirical Anatomy-Based Ablation vs Emphasize Map-Guided Substrate Ablation in Persistent Atrial Fibrillation : (COMPASS-AF)

Condition(s) studied

Investigational drug(s) / intervention(s)

Anatomy-based ablation: In the empirical anatomy-based ablation strategy group, pulmonary vein isolation (PVI) will be performed using pulsed-field ablation (PFA) with a single-shot multielectrode catheter. For each pulmonary vein, approximately 4-10 pulse applications will be delivered depending on the catheter position, with each application consisting of several seconds of pulse delivery. The catheter will be positioned around the PV ostia, and electrical isolation will be achieved by utilizing various catheter configurations as necessary. The energy settings and application methods for PFA in this study will follow the manufacturer's recommended protocols and established methods from prior clinical studies. Additionally, the creation of supplementary lesion sets is permitted at the operator's discretion.

Emphasize map-guided ablation: In the Emphasize map-guided substrate ablation group, ablation will be performed using a contact force-sensing irrigated radiofrequency (RF) catheter. Following pulmonary vein isolation (PVI), an Emphasize map will be acquired during atrial fibrillation (AF) using the EnSite X mapping system. Based on this map, electrophysiologically significant pathologic substrates will be evaluated, and additional substrate ablation will be performed. Subsequently, electrical cardioversion will be conducted to restore sinus rhythm. If sinus rhythm is not maintained or if AF is re-induced, an additional Emphasize map may be acquired in the right atrium (RA), and RA substrate ablation can be performed if necessary.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Recurrence of atrial tachyarrhythmia — From 3 months to 12 months after the index procedure
  Any documented atrial tachyarrhythmias excluding the initial 3-month blanking period. Documented atrial tachyarrhythmias (atrial fibrillation, atrial flutter, atrial tachycardia) were defined as follows: * Atrial tachyarrhythmias documented in 12 lead ECG * Atrial tachyarrhythmias of more than 30 seconds in Holter monitoring Recorded as a binary outcome (presence or absence of recurrence)

Trial sites (2)

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