Overview
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
Description
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:
- Empirical pulmonary vein isolation in all patients (current standard of care).
- 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.
Eligibility
Inclusion Criteria:
Ablation-naïve patients with:
- 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)
Exclusion Criteria:
- Previous cardiac ablation
- Age \<18 years
- Pregnancy or lactation
- Previous stroke/TIA
- Severe left ventricular dysfunction (LVEF \<35%)
- Renal failure (GFR \<30 ml/min)
- Dermal disease or hypersensitivity predisposing for skin irritation or exanthema