Atrial Fibrillation (AF)ELISA-AFNCT07358611
Non-invasive Mapping-Guided Atrial Fibrillation Ablation
A study testing Non-invasive mapping-guided ablation in people with Atrial Fibrillation (AF), run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Non-invasive mapping-guided ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic, University of Barcelona
Barcelona, 08036
Ivo Roca-Luque, M.D., Ph.D., iroca@clinic.cat
Lluis Mont, M.D., Ph.D., lmont@clinic.cat
About this study
Official title: 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).
Read more
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
Read the 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
- 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).
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Non-invasive mapping-guided ablation
- Keywords
- Atrial fibrillation, Catheter ablation, Atrial fibrillation drivers, Personalized atrial fibrillation therapy, Electroanatomical mapping, Electrocardiographic imaging, Body surface mapping
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive mapping-guided ablationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive mapping-guided ablation | Experimental | 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. Receives: Procedure: Non-invasive mapping-guided ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute AF termination
Rate of acute AF termination (ro sinus rhythm or conversion into an organized atrial tachycardia) upon ablation
Measured: Procedural
Secondary outcomes (3)
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.
Measured: Days 91 to 365 post-ablation
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
Measured: Days 91 to 365 post-ablation
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
Measured: Day 0 to 30 post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start31 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivo Roca, Hospital Clinic of Barcelona
- Investigators
- Till F Althoff, M.D., Principal investigator, German Heart Center of the Charite, BerlinIvo Roca-Luque, M.D., Ph.D., Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358611
- Sponsor's protocol ID
- HCB/2024/1096
- Acronym
- ELISA-AF
- Status last verified
- Jul 2026
- First submitted
- 14 Jan 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data underlying published results will be provided upon reasonable request
Publications
Invers-Rubio E, Hernandez-Romero I, Reventos-Presmanes J, Ferro E, Guichard JB, Regany-Closa M, Pellicer-Sendra B, Borras R, Prat-Gonzalez S, Tolosana JM, Porta-Sanchez A, Arbelo E, Guasch E, Sitges M, Brugada J, Guillem MS, Roca-Luque I, Climent AM, Mont L, Althoff TF. Regional conduction velocities determined by noninvasive mapping are associated with arrhythmia-free survival after atrial fibrillation ablation. Heart Rhythm. 2024 Sep;21(9):1570-1580. doi: 10.1016/j.hrthm.2024.04.063. Epub 2024 Apr 16.
PubMed 38636930Althoff TF, Anderson RH, Goetz C, Petersen SE, Diaz PM, Nijveldt R, Maurovich-Horvat P, Bax J, Hussain S, Schmidt C, Spicer DE, Sanchez-Quintana D, Corsi C, Dossel O, Climent AM, Rodriguez B, Schotten U, Loewe A, Guillem MS, Cabrera JA, Merino JL, Wijnmaalen AP, Bertrand PB, de Groot N, Derval N, Didenko M, Donal E, Dweck MR, Ho SY. Regionalization of the atria for 3D electroanatomical mapping, cardiac imaging, and computational modelling: a clinical consensus statement of the European Heart Rhythm Association and the European Association of Cardiovascular Imaging of the ESC. Europace. 2025 Jul 1;27(7):euaf134. doi: 10.1093/europace/euaf134.
PubMed 40736086
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELectrocardiographic Imaging-guided Substrate Ablation in Patients With Atrial Fibrillation - a PILOT Study of a Personalized Therapy
- ClinicalTrials.gov ID
- NCT07358611
- Acronym / sponsor ID
- ELISA-AF / HCB/2024/1096
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial fibrillation, Catheter ablation, Atrial fibrillation drivers, Personalized atrial fibrillation therapy, Electroanatomical mapping, Electrocardiographic imaging, Body surface mapping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive mapping-guided ablation | Experimental | Procedure: Non-invasive mapping-guided ablationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- Previous cardiac ablation
- Age <18 years
- Pregnancy or lactation
- Previous stroke/TIA
- Severe left ventricular dysfunction (LVEF <35%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive mapping-guided ablationThe 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). | Procedure or surgery | Non-invasive mapping-guided ablation |
Primary outcome
Acute AF termination
Time frame: Procedural
Rate of acute AF termination (ro sinus rhythm or conversion into an organized atrial tachycardia) upon ablation
3 secondary outcomes
Proportion of patients with arrhythmia-free survival
Time frame: Days 91 to 365 post-ablation
Proportion of patients with AF-free survival
Time frame: Days 91 to 365 post-ablation
Rate of procedure-related complications
Time frame: Day 0 to 30 post-ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 38636930Invers-Rubio E, Hernandez-Romero I, Reventos-Presmanes J, Ferro E, Guichard JB, Regany-Closa M, Pellicer-Sendra B, Borras R, Prat-Gonzalez S, Tolosana JM, Porta-Sanchez A, Arbelo E, Guasch E, Sitges M, Brugada J, Guillem MS, Roca-Luque I, Climent AM, Mont L, Althoff TF. Regional conduction velocities determined by noninvasive mapping are associated with arrhythmia-free survival after atrial fibrillation ablation. Heart Rhythm. 2024 Sep;21(9):1570-1580. doi: 10.1016/j.hrthm.2024.04.063. Epub 2024 Apr 16.
- Background: PubMed 40736086Althoff TF, Anderson RH, Goetz C, Petersen SE, Diaz PM, Nijveldt R, Maurovich-Horvat P, Bax J, Hussain S, Schmidt C, Spicer DE, Sanchez-Quintana D, Corsi C, Dossel O, Climent AM, Rodriguez B, Schotten U, Loewe A, Guillem MS, Cabrera JA, Merino JL, Wijnmaalen AP, Bertrand PB, de Groot N, Derval N, Didenko M, Donal E, Dweck MR, Ho SY. Regionalization of the atria for 3D electroanatomical mapping, cardiac imaging, and computational modelling: a clinical consensus statement of the European Heart Rhythm Association and the European Association of Cardiovascular Imaging of the ESC. Europace. 2025 Jul 1;27(7):euaf134. doi: 10.1093/europace/euaf134.
- Individual participant dataSharing planned: No. Data underlying published results will be provided upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Till F Althoff, M.D. principal investigator
German Heart Center of the Charite, Berlin
Ivo Roca-Luque, M.D., Ph.D. principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive mapping-guided ablation in people with Atrial Fibrillation (AF), run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Till F Althoff, M.D. (+49 30 450513143, till.althoff@dhzc-charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute AF termination (time frame: Procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07358611, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.