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NCT Number: NCT07358611

Non-invasive Mapping-Guided Atrial Fibrillation Ablation

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic, University of Barcelona

Barcelona, 08036, Spain

Location status: Recruiting

Location contact

Ivo Roca-Luque, M.D., Ph.D.

CONTACT

[email protected]

Lluis Mont, M.D., Ph.D.

CONTACT

[email protected]

About this study

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 and 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

  • Empirical pulmonary vein isolation in all patients (current standard of care).
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • 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

Treatment and study plan

Non-invasive mapping-guided ablation

Procedure

The study intervention consists of

  • Empirical pulmonary vein isolation (current standard of care) plus
  • 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).

Primary outcomes

  1. Acute AF termination

    Time frame: Procedural

    Rate of acute AF termination (ro sinus rhythm or conversion into an organized atrial tachycardia) upon ablation

Secondary outcomes

  1. Proportion of patients with arrhythmia-free survival

    Time frame: Days 91 to 365 post-ablation

    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.

  2. Proportion of patients with AF-free survival

    Time frame: Days 91 to 365 post-ablation

    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

  3. Rate of procedure-related complications

    Time frame: Day 0 to 30 post-ablation

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ivo Roca-Luque, M.D., Ph.D.

CONTACT

[email protected]

+34 93 2271778

Till F Althoff, M.D.

CONTACT

[email protected]

+49 30 450513143

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: ELISA-AF

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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