Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping
NCT ID: NCT07320560
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2026-01-15
2027-12-31
Brief Summary
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* 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
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Detailed Description
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General Strategy:
Patients with persistent AF planned for catheter ablation are eligible in case of left atrial enlargement.
The study intervention consists of two steps:
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 temporal Stability of local 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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 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).
Interventions
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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 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).
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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German Heart Institute
OTHER
Responsible Party
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Till Althoff
Head of Research and Principal Investigator
Principal Investigators
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Till F Althoff, M.D.
Role: PRINCIPAL_INVESTIGATOR
German Heart Center of the Charitè, Berlin, Department of Cardiology, Angiology and Intensive Care Medicine
Locations
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German Heart Center of the Charité, Charité University Hospital Berlin
Berlin, , Germany
Frankfurt University Heart and Vascular Center
Frankfurt am Main, , Germany
Central Lisbon University Hospital Centre (CHULC), Hospital de Santa Marta
Lisbon, , Portugal
Hospital Clinic, University of Barcelona
Barcelona, , Spain
Gregorio Marañón General University Hospital
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Role: backup
References
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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.
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.
Other Identifiers
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EA1/204/25
Identifier Type: -
Identifier Source: org_study_id
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