Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping

NCT07320560 | Recruiting

• 1 other identifier: EA1/204/25
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 5

Brief Summary

This pilot study investigates if non-invasive global mapping can guide catheter ablation of atrial fibrillation (AF) by defining personalized targets based on the temporal Stability of local Atrial High-Rate Activity (SAHRA). The study also assesses efficacy and safety of this approach and evaluates potential signals of harm. The main questions it aims to answer are:

• Does ablation of targets defined by non-invasive 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 non-invasive 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

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial Fibrillation; Catheter Ablation; Non-invasive mapping; Global Mapping; Electrocardiographic Imaging; Body Surface Mapping; Atrial fibrillation drivers

Outcome Measures

Primary Outcomes (1)

• Rate of acute AF termination

  Acute AF termination (to sinus rhythm or conversion into an organized atrial tachycardia) upon ablation

  Procedural

Secondary Outcomes (5)

• Proportion of patients with arrhythmia-free survival

  Days 91 to 365 post-ablation

• Proportion of patients with AF-free survival

  Days 91 to 365 post-ablation

• Time to arrhythmia recurrence

  Days 91 to 365 post-ablation

• Time to AF recurrence

  Days 91 to 365 post-ablation

• Rate of procedure-related complications

  Day 0 to 30 post-ablation

Other Outcomes (7)

• Procedure time

  Day 0

• Total left atrium indwelling time

  Day 0

• Fluoroscopy time

  Day 0

Study Arms (1)

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.

Procedure: Non-invasive mapping-guided ablation

Interventions

Non-invasive mapping-guided ablation PROCEDURE

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 temporal Stability of local Atrial High-Rate Activity (SAHRA) using a non-invasive global mapping system (Acorys, Corify Care). Local high-rate activity is confirmed by endocardial mapping. * 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).

Non-invasive mapping-guided ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• German Heart Institute: lead

Study Sites (5)

German Heart Center of the Charité, Charité University Hospital Berlin

Berlin, 10117, Germany

RECRUITING

Frankfurt University Heart and Vascular Center

Frankfurt am Main, 60598, Germany

NOT YET RECRUITING

Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta

Lisbon, 1169-024, Portugal

NOT YET RECRUITING

Hospital Clinic, University of Barcelona

Barcelona, 08036, Spain

NOT YET RECRUITING

Gregorio Marañón General University Hospital

Madrid, 28007, Spain

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 38636930 BACKGROUND

• Althoff 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.

  PMID: 40736086 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Till F Althoff, M.D.

  German Heart Center of the Charitè, Berlin, Department of Cardiology, Angiology and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Till F Althoff, M.D.

CONTACT

0049 30 450613163; till.althoff@dhzc-charite.de

Gerhard Hindricks, M.D.

CONTACT

030450613163; gerhard.hindricks@dhzc-charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Principal Investigator

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: January 6, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); PT (1); ES (2)