RecruitingNot ApplicableNCT07358611

Non-invasive Mapping-Guided Atrial Fibrillation Ablation

ELectrocardiographic Imaging-guided Substrate Ablation in Patients With Atrial Fibrillation - a PILOT Study of a Personalized Therapy


Sponsor

Hospital Clinic of Barcelona

Enrollment

30 participants

Start Date

Jan 31, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this pilot study is to test if noninvasive global mapping can guide catheter ablation defining personalized targets and improve the therapy of atrial fibrillation. It will also test the safety of such an approach. The main questions it aims to answer are: * Does ablation of targets defined by noninvasive 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 noninvasive 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 spatiotemporal Stability of 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 (Althoff et al. 2025).


Locations(1)

Hospital Clinic, University of Barcelona

Barcelona, Spain

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NCT07358611


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