Atrial Fibrillation (AF)
Conditions
Keywords
Atrial Fibrillation, Catheter Ablation, Non-invasive mapping, Global Mapping, Electrocardiographic Imaging, Body Surface Mapping, Atrial fibrillation drivers
Brief 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
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 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.
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 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).
Sponsors
German Heart Institute
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 |
|---|---|---|
| Rate of acute AF termination | Procedural | Acute AF termination (to 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. |
| Time to arrhythmia recurrence | Days 91 to 365 post-ablation | 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 to AF recurrence | Days 91 to 365 post-ablation | 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | Day 0 | Skin-to-skin duration of the ablation (procedural endpoint) |
| hsTroponin on day 1 post-ablation | Day 1 post-ablation | Procedural endpoint |
| Total left atrium indwelling time | Day 0 | Procedural endpoint |
| Fluoroscopy time | Day 0 | Procedural endpoint |
| Hemolysis marker levels on day 1 post-ablation | Day 1 post-ablation | Procedural endpoint |
| GFR on day 1 post-ablation | Day 1 post-ablation | Procedural endpoint |
| Proportion of patients with acute renal failure | Day 0 to 30 post-ablation | Procedural endpoint |
Countries
Germany, Portugal, Spain
Contacts
Primary ContactTill F Althoff, M.D.
Backup ContactGerhard Hindricks, M.D.
Outcome results
None listed