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RECRUITING
NCT07320560
NA

Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping

Sponsor: German Heart Institute

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-01-15

Completion Date

2027-12-31

Last Updated

2026-01-06

Healthy Volunteers

No

Interventions

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).

Locations (5)

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

Hospital Clinic, University of Barcelona

Barcelona, Spain

Gregorio Marañón General University Hospital

Madrid, Spain