NCT07320560

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: German Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
PROCEDURE	Non-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).

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

5 sites across 3 countries: Germany, Portugal, Spain