Comparing Two Imaging Methods to Guide Pulsed Field Ablation for Atrial Fibrillation
Compares two guidance methods for heart rhythm ablation in adults with paroxysmal atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation
Key facts
- Where
- Ancona, ItalySee the site
Where in Italy
- Marche Polytechnic University / Marche University HospitalAncona, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mitera Hospital
- Trial code
- NCT07772518
- Record updated
- 19 August 2026
- Original 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.Read full original descriptionShow less
Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation - the PFA-VISION Randomized Trial (Pulsed Field Ablation - Visualization and Imaging Strategies for Isolation Outcomes in Paroxysmal Atrial fibrillatioN)
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.
Inclusion: History of paroxysmal AF; Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.
Exclusion: History of previous left atrial ablation; NYHA class III/IV heart failure; Intracardiac thrombus or other conditions making left atrial instrumentation unsafe; Severe valvular disease; eGFR < 30 mL/min/1.73 m2; Any contraindication to AF catheter 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; Major cardiovascular events within 90 days; Secondary AF owing to reversible causes.