Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-invasive mapping-guided ablation: The study intervention consists of 1. Empirical pulmonary vein isolation (current standard of care) plus 2. A personalized ablation approach targeting up to three additional atrial regions which harbour critical AF-perpetuating sources: * Target regions are selected based on the temporal Stability of local Atrial High-Rate Activity (SAHRA) using a non-invasive global mapping system (Acorys, Corify Care). Local high-rate activity is confirmed by endocardial mapping. * Selected target regions displaying stable high-rate activity are isolated or homogenized according to predefined regional borders based on the 15-segment bi-atrial model of the EHRA and EACVI Clinical Consensus on Standardized Atrial Regionalization (Althoff et al. 2025).

Study summary

This pilot study investigates if non-invasive global mapping can guide catheter ablation of atrial fibrillation (AF) by defining personalized targets based on the temporal Stability of local Atrial High-Rate Activity (SAHRA). The study also assesses efficacy and safety of this approach and evaluates potential signals of harm. The main questions it aims to answer are:

* Does ablation of targets defined by non-invasive global mapping improve rates of acute atrial fibrillation termination?
* Does such a personalized ablation approach reduce arrhythmia recurrence rates? Researchers will compare the results of the personalized ablation approach with comparable patients that had undergone a conventional "empirical" ablation approach (pulmonary vein isolation).

Participants will:

* Undergo a personalized catheter ablation approach employing both a non-invasive global mapping system and a conventional intracardiac mapping system
* Visit the clinic 3, 6 and 12 months after ablation for clinical follow-up
* Schedule a telephone visit 9 and 24 months after ablation for clinical follow-up

Eligibility

Primary outcome measure(s)

• Rate of acute AF termination — Procedural
  Acute AF termination (to sinus rhythm or conversion into an organized atrial tachycardia) upon ablation

Trial sites (5)

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