Non-invasive Mapping-Guided Atrial Fibrillation Ablation (ELISA-AF)

January 14, 2026 updated by: Hospital Clinic of Barcelona

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

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

  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).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ivo Roca-Luque, M.D., Ph.D.
  • Phone Number: +34 93 2271778
  • Email: iroca@clinic.cat

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic, University of Barcelona
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Ablation-naïve patients with:

  1. Persistent AF planned for catheter ablation plus
  2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-invasive mapping-guided ablation
In this arm patients undergo a personalized ablation approach: In addition to conventional pulmonary vein isolation, additional target regions will be ablated based on non-invasive global mapping.
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 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute AF termination
Time Frame: Procedural
Rate of acute AF termination (ro sinus rhythm or conversion into an organized atrial tachycardia) upon ablation
Procedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Days 91 to 365 post-ablation
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
Day 0 to 30 post-ablation
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
Days 91 to 365 post-ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Till F Althoff, M.D., German Heart Center of the Charite, Berlin
  • Principal Investigator: Ivo Roca-Luque, M.D., Ph.D., Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 31, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2024/1096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data underlying published results will be provided upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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