RecruitingNot ApplicableNCT07320560

Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping

Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping - the CURE-AF Pilot Study

Sponsor

German Heart Institute

Enrollment

45 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a personalized approach to heart rhythm ablation — using non-invasive full-heart electrical mapping to guide the procedure — improves outcomes for people with persistent atrial fibrillation (a common irregular heartbeat) and an enlarged left heart chamber. **You may be eligible if...** - You have persistent atrial fibrillation (ongoing irregular heartbeat) and are planning to have a catheter ablation procedure for the first time - Your left atrium (left upper heart chamber) is enlarged, confirmed by echocardiogram or cardiac imaging **You may NOT be eligible if...** - You have had a previous cardiac ablation procedure - You are under 18 years old - You are pregnant or breastfeeding - You have had a stroke or TIA (mini-stroke) - Your heart's pumping function is severely reduced (ejection fraction below 35%) - You have significant kidney failure (GFR below 30 mL/min) - You have a skin condition or sensitivity that would prevent electrode placement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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).