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Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation

Sponsor: Mitera Hospital • ClinicalTrials.gov ID: NCT07772518

Registry updated: 2026-08-19

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Description

This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure. The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months. The primary safety endpoint will be the incidence of predefined safety outcomes.

Interventions

In the ICE group, positioning/contact of the ablation catheter will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping. (Other)
Ablation procedure (electrical isolation of the pulmonary veins) will be performed according to routine clinical practice. In the ICE group, positioning of the ablation catheter and confirmation of contact with the targeted tissue will be performed under ICE guidance. In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping with the FARAVIEW system (OPAL HDx, software version 7.0, Boston Scientific). PFA will be delivered using field-tag feature ensuring number of applications and stacking as suggested by IFU. In the mapping group, the use of ICE will only be allowed to guide the transseptal puncture in order to ensure procedural safety in both groups.

Eligibility criteria

Inclusion Criteria: * History of paroxysmal AF. * Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system. Exclusion Criteria: * Any contraindication to AF catheter ablation. * History of previous left atrial ablation. * Need for additional ablation beyond pulmonary vein isolation. * Inability to provide written informed consent. * Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety. * eGFR \< 30 mL/min/1.73 m2 * NYHA class III/IV heart failure * Major cardiovascular events within 90 days * Secondary AF owing to reversible causes * Intracardiac thrombus or other conditions making left atrial instrumentation unsafe * Severe valvular disease

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Locations

University Hospital Centre Zagreb (KBC Zagreb) — Zagreb, Croatia
Department of Cardiology, IKEM — Prague, Czechia
Hygeia Hospital, 8th Cardiology Department — Athens, Greece
Heart and Vascular Center, Semmelweis University — Budapest, Hungary
Marche Polytechnic University / Marche University Hospital — Ancona, Italy
Grochowski Hospital, Centre of Postgraduate Medical Education — Warsaw, Poland
Department of Arrhythmology, Institute of Cardiovascular Diseases — Banská Bystrica, Slovakia
University Medical Centre Ljubljana (UKC Ljubljana) — Ljubljana, Slovenia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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