Atrial Fibrillation (AF)
Conditions
Keywords
Atrial fibrillation, Catheter ablation, Atrial fibrillation drivers, Personalized atrial fibrillation therapy, Electroanatomical mapping, Electrocardiographic imaging, Body surface mapping
Brief summary
The goal of this pilot study is to test if noninvasive global mapping can guide catheter ablation defining personalized targets and improve the therapy of atrial fibrillation. It will also test the safety of such an approach. The main questions it aims to answer are: * Does ablation of targets defined by noninvasive 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 noninvasive 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
Detailed 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 and 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 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 spatiotemporal Stability of 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 (Althoff et al. 2025).
Interventions
PROCEDURENon-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 spatiotemporal Stability of 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 (Althoff et al. 2025).
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ablation-naïve patients with: 1. Persistent AF planned for catheter ablation plus 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute AF termination | Procedural | Rate of acute AF termination (ro sinus rhythm or conversion into an organized atrial tachycardia) upon ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with arrhythmia-free survival | Days 91 to 365 post-ablation | 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. |
| Proportion of patients with AF-free survival | Days 91 to 365 post-ablation | 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 |
| Rate of procedure-related complications | Day 0 to 30 post-ablation | 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 |
Countries
Spain
Contacts
CONTACTTill F Althoff, M.D.
CONTACTIvo Roca-Luque, M.D., Ph.D.
PRINCIPAL_INVESTIGATORTill F Althoff, M.D.
German Heart Center of the Charite, Berlin
PRINCIPAL_INVESTIGATORIvo Roca-Luque, M.D., Ph.D.
Hospital Clinic of Barcelona
Outcome results
None listed