Non-invasive Mapping-Guided Atrial Fibrillation Ablation
ConditionAtrial Fibrillation (AF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Clinic of Barcelona
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Previous cardiac ablation
Age <18 years
Pregnancy or lactation
Previous stroke/TIA
Trial design
Design model
Single group
Treatments tested in this trial
Non-invasive mapping-guided ablation
Procedure/SurgeryThe 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).
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Non-invasive mapping-guided ablationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute AF termination
Rate of acute AF termination (ro sinus rhythm or conversion into an organized atrial tachycardia) upon ablation
Time frame
ProceduralSecondary outcomes
1
Proportion of patients with arrhythmia-free survival
Absence of any atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between days 91 and 365 post ablation. AF, AFL or AT will qualify as a recurrence after ablation if it lasts 30 s or longer.
Time frame
Days 91 to 365 post-ablation2
Proportion of patients with AF-free survival
Absence of atrial fibrillation \[AF\] between days 91 and 365 post ablation. AF will qualify as a recurrence after ablation if it lasts 30 s or longer
Time frame
Days 91 to 365 post-ablation3
Rate of procedure-related complications
Composite safety endpoint composed of: * cardiac tamponade requiring drainage * persistent phrenic nerve palsy lasting \>24 hours * serious vascular complications requiring intervention * stroke/TIA * atrioesophageal fistula * death
Time frame
Day 0 to 30 post-ablationSponsors and contacts
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Source ClinicalTrials.gov