Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping

ConditionAtrial Fibrillation (AF)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorGerman Heart Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Persistent AF planned for catheter ablation plus

Left atrial enlargement (LA diameter ≥45 mm or LA volume index ≥35ml/m2 or LA area ≥20 cm2)

Disqualifiers

Previous cardiac ablation

Age <18 years

Pregnancy or lactation

Previous stroke/TIA

Trial design

Design model

Single group

Treatments tested in this trial

Non-invasive mapping-guided ablation
Procedure/Surgery
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).

Treatment groups

45 Participants

are divided into 1 treatment group

Group A: Non-invasive mapping-guided ablationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Rate of acute AF termination

Acute AF termination (to sinus rhythm or conversion into an organized atrial tachycardia) upon ablation

Time frame

Procedural

Secondary outcomes

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