Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping
Recruiting · NCT07320560 · Interventional (participants receive a specific treatment) · Lead sponsor: German Heart Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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
Where it is running
5 locations listed.
- Hospital Clinic, University of Barcelona - Barcelona, Spain
- German Heart Center of the Charité, Charité University Hospital Berlin - Berlin, Germany
- Frankfurt University Heart and Vascular Center - Frankfurt am Main, Germany
- Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta - Lisbon, Portugal
- Gregorio Marañón General University Hospital - Madrid, Spain