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
The aim of this study is to test the feasibility and potential of a personalized, non-invasive mapping-guided ablation approach in patients with persistent atrial fibrillation (AF), who are unlikely to benefit from empirical pulmonary vein isolation alone. As a pilot study, it is designed to assess feasibility and procedural efficacy as well as potential signals of harm. General Strategy: Patients with persistent AF planned for catheter ablation are eligible in case of left atrial enlargement. The study intervention consists of two steps: 1. Empirical pulmonary vein isolation in all patients (current standard of care). 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). * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
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).
German Heart Center of the Charité, Charité University Hospital Berlin
Berlin, Germany
RECRUITINGFrankfurt University Heart and Vascular Center
Frankfurt am Main, Germany
NOT_YET_RECRUITINGCentral Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta
Lisbon, Portugal
NOT_YET_RECRUITINGHospital Clinic, University of Barcelona
Barcelona, Spain
NOT_YET_RECRUITINGGregorio Marañón General University Hospital
Madrid, Spain
NOT_YET_RECRUITINGRate of acute AF termination
Acute AF termination (to sinus rhythm or conversion into an organized atrial tachycardia) upon ablation
Time frame: Procedural
Proportion of patients with arrhythmia-free survival
Absence of any atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.
Time frame: Days 91 to 365 post-ablation
Proportion of patients with AF-free survival
Absence of atrial fibrillation \[AF\] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer.
Time frame: Days 91 to 365 post-ablation
Time to arrhythmia recurrence
Time to first atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.
Time frame: Days 91 to 365 post-ablation
Time to AF recurrence
Time to first atrial fibrillation \[AF\] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer.
Time frame: Days 91 to 365 post-ablation
Rate of procedure-related complications
Composite safety endpoint composed of: * cardiac tamponade requiring drainage * persistent phrenic nerve palsy lasting \>24 hours * serious vascular complications requiring intervention * stroke/TIA * atrioesophageal fistula * death
Time frame: Day 0 to 30 post-ablation
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