Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping
Recruiting now · Not applicable
Conditions studied: Atrial Fibrillation (AF)
In brief
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
Key facts
- Study ID
- NCT07320560
- Run by
- German Heart Institute
- People needed
- 45
- Starts
- 2026-01-15
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
- German Heart Center of the Charité, Charité University Hospital Berlin — Berlin, Germany (enrolling)
- Frankfurt University Heart and Vascular Center — Frankfurt am Main, Germany
- Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta — Lisbon, Portugal
- Hospital Clinic, University of Barcelona — Barcelona, Spain
- Gregorio Marañón General University Hospital — Madrid, Spain
Full record on ClinicalTrials.gov
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