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

NCT07772518

RecruitingNA

Sponsor: Mitera Hospital

Conditions: Paroxysmal Atrial Fibrillation (PAF)

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.

Countries: Croatia, Czechia, Greece, Hungary, Italy, Poland, Slovakia, Slovenia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (8)

Zagreb, Croatia
Prague, Czechia
Athens, Greece
Budapest, Hungary
Ancona, Italy
Warsaw, Poland
Banská Bystrica, Slovakia
Ljubljana, Slovenia