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

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

Inclusion Criteria3

  • 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 Criteria7

  • 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

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).


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

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NCT07320560


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